cvc chronicle fall 2013

CANADIAN

VIGOUR CENTRE

Inside this

issue:

CVC is proud

to be a

University of Alberta

Centre

Bridging hearts

and minds to enhance

cardiovascular care

www.vigour.ualberta.ca

Letter -

PW Armstrong

1

Trial Updates 2-5

Monitoring

6

CVC

News 6

CVC

Publications 7-8

Recently I have been engaged with my colleagues at the Canadian VIGOUR Centre in creating our annual report

for 2012, which celebrates CVC’s 15th year as an ARO (academic research organization), and a significant wealth

of trial experience, along with peer reviewed publications and ample mentoring opportunities for our next

generation of health researchers. The exercise of generating an annual report gives me pause to reflect on our

collective contributions to date, but also to examine and articulate our future direction(s) as it relates to our

overall role in the cardiovascular research arena in Canada and our raison d’être. As part of our annual faculty

Advance (I avoid Retreats), we illustrated our organizational purpose and future direction into what we term the

CVC Compass, as borrowed from the Harvard Business Review’s assessment of the Four Seasons Hotel

approach. This compass is now displayed on the back cover of this edition of the Chronicle, in our latest annual

report, as well as our web site (http://www.vigour.ualberta.ca/About.aspx). This exercise of “calibrating our

compass”, that is, setting our objectives and strategic priorities, has helped us in reflecting on who we are and

where we are headed. I also believe it will be useful to new staff and our community of investigators and many

colleagues worldwide.

Although the term ARO is in common use, its meaning is less clear: ironically this is especially true for many of

our colleagues within the university and health care environment. Four years ago I attempted a definition which

still resonates and is referred to in our annual report. I include it here to remove unnecessary ambiguity:

“An ARO in my view possesses scholarly values of inquiry and truth, shares knowledge in an ethical framework, is dedicated

to enhancing public health, and values discovery, novel approaches and methodologies over profit. It strives to achieve the

operational efficiency of a CRO (contract research organization) and is directly linked to patient care and the bedside. It is

almost always embedded in a university, functions on a not-for-profit basis, is committed to the education of the next

generation of professionals and fulfills its contract with society by emphasizing the public good.”

In these challenging times for clinical research, collaborators are key to a preferred future. Our faculty has been

significantly strengthened by the addition of Shaun Goodman from the University of Toronto who is also an

Adjunct Professor of Medicine at the University of Alberta. Shaun is now playing a leadership role in two of our

major CVC trials described elsewhere in the Chronicle and is actively engaged in our overall activities. This

development signals a new east-west Canadian axis in clinical research. A key responsibility Shaun holds, as the

Heart & Stroke Foundation Polo Chair, is to assist in mentoring young clinical investigators, a commitment we

enthusiastically share. We continue and have recently enriched our long standing collaboration with the Duke

Clinical Research Institute, now led by Eric Peterson. This north-south axis is key to the future of our

collaborative North American research endeavors as an ARO and fundamental to where our compass points.

As this edition of the Chronicle takes flight, our attention turns to the Canadian Cardiovascular Society meeting

in Montreal October 17-20th where our PROACT work will unfold and the American Heart Association meeting

in November where new insights from STREAM into aborted MI, the approach to rescue coronary intervention

and the much anticipated one year follow up, will be presented.

We invite our many friends and co-investigators to join us during the 19th annual Beyond 2000 symposium to be

held Thursday morning October 17, 2013 and look forward to seeing them participate in what promises to be a

terrific program as noted in this edition of the Chronicle. For more information on the Beyond 2000 symposium,

please go to the website www.beyond2000.org.

With kind regards,

Paul W. Armstrong, MD

Fall 2013 Volume 17, No. 2

The Canadian

Cardiac Chronicle Letter from Dr. Paul Armstrong:

http://www.beyond2000.org

The Canadian Cardiac Chronicle

IMProved Reduction of

Outcomes: Vytorin Efficacy

International Trial

Sponsored by Merck & Co.

Inc., (previously Schering-

Plough Research Institute)

this trial is a multicenter,

double-blind, randomized

study to establish the

clinical benefit and safety of

Vytorin (ezetimibe/

simvastatin Tablet) vs.

simvastatin monotherapy in

high-risk patients

presenting with acute

coronary syndrome.

ClinicalTrials.gov

Identifier: NCT00202878

IMPROVE-IT

The IMPROVE-IT trial is projected to reach

the protocol-defined number of clinical

endpoints in 2014. Patient retention continues

to be paramount to ensuring we reach our

target number of endpoints. The countdown

is on as we head towards the finish line!

In preparing the database for study closure,

Memo #408 recently came out, where QC of

AEs and potential clinical endpoints is being

conducted. Your cooperation in addressing

any of these important “AEQC” data queries

within 10 days is appreciated.

Reminders:

(1) CVC no longer tracks REB submissions/

acknowledgements of external SAEs. Though

sites must submit external SAEs to their REBs,

per their REB guidelines, they no longer need

to send copies of their REB correspondence to

CVC for these external safety reports. This

documentation should be filed at your site.

(2) Should a patient permanently discontinue

study drug, please remember to make the

withdrawal call in IVRS as well.

Data Clean Up – Commendations to the

following sites that have achieved 100% clean

data as of Sep06’2013:

2052 – Vancouver General Hospital,

PI—Dr. Wong, SC - Naomi Uchida

2054 – Surrey Memorial Hospital,

PI—Dr. Cheung, SC - Tracy Cleveland

2067 – Scarborough Cardiology Research,

PI—Dr. Mukherjee, SC - Kim Brown

2071 – Yamaska (CSSSHY),

PI—Dr. Brossoit, SC - Celine Peck

2075 – Montreal General Hospital,

PI—Dr. Huynh, SC - Barbara St. Jacques

2080 – Hôpital Pierre Le Gardeur,

PI—Dr. Gosselin, SC - Margaux David

2089 – Hôpital Laval,

PI—Dr. DeLarochelliere, SC - Melanie

Roy

2090 – St. Catharines Hospital,

PI—Dr. Pallie, SC - Sheila Krekorian

2098 – Hôtel-Dieu de Lévis,

PI—Dr. Grondin, SC - Noella Bilodeau

CEC Adjudicated Events – please remember to

submit any outstanding (de-identified) source

documents to the CEC.

For further information, please contact Clinical

Trial Project Lead, Jodi Parrotta at

1-800-707-9098, ext. 3 or by email at

[email protected].

STABILITY

Thanks to all our Canadian sites who have

been working hard toward study closeout and

quickly answering any outstanding queries.

As we work to close-out the regulatory files

for the study, remember if you have not al-

ready submitted your end of study financial

disclosure forms and ethics study closeout

letters please email or fax them to us now at

780-492-0613. We will be doing one final

review/reconciliation of the files and contacting

you to collect any of the final documents that

we may be missing.

This is an exciting time for the trial as we all

anticipate the presentation of the results in the

near future.

For further information, please contact Assis-

tant Director, Clinical Trials, Tracy Temple at

1-800-707-9098 Option 5 or by email at

[email protected].

STabilisation of

Atherosclerotic plaque By

Initiation of darapLadIb

TherapY

Sponsored by Glaxo

SmithKline, this trial is a

randomized, placebo-

controlled, double-blind,

parallel group, multicenter,

event-driven clinical

outcomes study of

darapladib versus placebo

in subjects with chronic

coronary heart disease to

compare the incidence of

major adverse

cardiovascular events.

ClinicalTrials.gov Identifier: NCT00799903

http://www.hdl.qc.ca/

mailto:[email protected]

Volume 17, No. 2

Exenatide Study of

Cardiovascular Event

Lowering

Sponsored by Amylin

Pharmaceuticals, Inc. this

trial is a pragmatic, long

term, placebo-controlled,

double-blinded trial which

seeks to characterize the

effects of exenatide once

weekly on cardiovascular

(CV) -related outcomes in

patients with type 2

diabetes when added to

the current usual care for

glycemic control in a

standard care setting.

ClinicalTrials.gov Identifier: NCT01144338

After careful consideration of the protocol in

early 2013, it was decided that modifications to

the protocol and trial processes were neces-

sary. Input was received from many trial col-

laborators and the next phase was initiated in

July 2013. We are pleased to report that the

updated processes made a smooth transition

and as of 27 September 2013, 116 patients

have been randomized. The data from the patients enrolled in

2011/2012 will be presented at the Canadian

Cardiovascular Congress in Montreal on

It has been a busy few months for the EXSCEL

trial. Global enrollment is now over 7900 with

Canada having enrolled 293 patients. Canada

currently has 24 sites activated and we are

excited to announce that we are planning for

an upcoming expansion of 5 new Canadian

sites.

The Amendment 4 transition is now well

underway with the first wave of Canadian sites

already successfully transitioned. Our goal is to

have all sites transitioned by the end of

October; to that end we will continue to work

closely with our sites. Please remember that

prior to transitioning, all regulatory documents

must be in order and all study staff must have

received appropriate training. If you have any

questions or concerns related to the transition

process, please contact the Project Team.

Thank you for all your hard work in cleaning

up the study data prior to the data lock on

August 30th in preparation for the next DSMB

meeting in October. We were able to achieve

94% site clean data. A special thank you to

those sites achieving 100% site clean data:

Vancouver General Hospital,

PI—Dr. T. Elliott, SC - Marla Inducil

Fraser Clinical Trials,

PI—Dr. R. Kuritzky, SC - Carol Marchand

Centre de Cardiologie et de Recherche

Clinique de Laval,

PI—Dr. Y. Robitaille, SC - Christine

Masson

St. Michael’s Health Centre,

PI—Dr. L. Leiter, SC - Danielle Bedard

McMaster University,

PI—Dr. Z Punthakee, SC - Irene Stanton

EXSCEL

Institut Universitaire de Cardiologie et de

Pneumologie de Québec,

PI—Dr. F. Dube, SC - Marilène Bolduc

Clinical Trial Unit at the University of

Calgary,

PI—Dr. R. Sigal, SC - Mary Ann

Clearwaters

Congratulations to our top five recruiters as of

September 5th 2013:

Dr. Ronald Bourgeois, Moncton NB – 38

pts

Dr. Thomas Elliott, Vancouver BC – 26

pts

Dr. Richard Dumas, Laval QC – 23 pts

Dr. Vincent C. Woo, Winnipeg MB – 21

pts

Dr. Ron Sigal, Calgary AB – 20 pts

As a reminder Courtney Bryden will be

starting her maternity leave on Sept 19 and

Amanda Carapellucci has stepped in as her

replacement over the next year. Moving

forward please contact Amanda and Diane for

all trial related questions. We would like to

thank Courtney for all her hard work on

EXSCEL and wish her all the best. (See

Amanda’s bio on page 6 announcements.)

We thank you for your continued support of

the EXSCEL trial!

For further information please contact Clinical

Trial Project Lead, Amanda Carapellucci at 1-

800-707-9098 (Ext 2) or by email at

[email protected] or Diane

Camara at 1-800-725-6585 or by email at

[email protected].

PROACT—A local initiative Providing Rapid Out of

Hospital Acute

Cardiovascular Treatment

An Edmonton-region local

initiative sponsored by the

University Hospital

Foundation and the

Mazankowski Alberta

Heart Institute. Additional

support for point of care

meters provided by Alere

Inc.

ClinicalTrials.gov


PROACT

October 20, 2013 @ 0930 by Dr. Justin Eze-

kowitz - “Providing Rapid Out Of Hospital

Acute Cardiovascular Treatment (PROACT-3):

Insights from the Field”.

For further information please contact Paula

Priest at 1-800-707-9098 (ext 9) or email at

[email protected].



ODYSSEY OUTCOMES

Sponsored by Sanofi-

aventis Recherche &

Développement this is a

randomized, double-blind,

placebo-controlled, parallel

-group study to evaluate

the effect of SAR236553/

REGN727 on the

occurrence of cardiovascu-

lar events in patients who

have recently experienced

an Acute Coronary

Syndrome.

ClinicalTrials.gov


The ODYSSEY Outcomes study is now well

underway around the world with over 900

patients randomized. In Canada we have

activated over 20 sites and are looking forward

to seeing screening and recruitment efforts

increase throughout the next couple months at

all sites. Congratulations to Dr. Ronald Bourgeois and

the team (Sub-Investigator, Dr. Daniel Landry;

Study Coordinators Glenda Shea-Landry,

Jennifer Lambert and Karen Boyd) at G.A.

Research Associates in Moncton, NB for

screening and randomizing the first patient in

Canada! This is a significant milestone for the

study in Canada and many thanks for all your

hard work!

We would also like to acknowledge the

following sites that we have added to the “first

patient randomized list” for the study. Keep

up the great work!

Dr. James Cha, Judy Otis and Elizabeth

Burke in Oshawa, ON

Dr. Manohara Senaratne, Robin Varughese

and Denali Perera in Edmonton, AB

Dr. Christopher Lai and Marnie Jarvis in

Thunder Bay, ON

Dr. Paul MacDonald and Joy Howard

in Sydney, NS

Dr, Jan Kornder, Dale Kastanis and Lynn

Breakwell in Surrey, BC

We will be working hard to get the remainder

of our sites activated in the next few months.

Don’t forget to get all your training complete

and regulatory in while you are waiting on

contracts and ethics!

We would like to send out the challenge

to all of our sites to put all eyes on

ODYSSEY over that next month and

let’s see how many patients we can find

in Canada!

For those sites that have now screened and/or

randomized a patient, don’t forget to complete

your CRF’s and answer any open queries. We

have had many great questions over the last

several months, especially from those of you

starting to screen and recruit patients. Keep

them coming and watch for FAQ’s in the

newsletters and updates sent out to you

throughout the trial.

We are still recruiting a few final sites for this

study so if you are interested in hearing more

about ODYSSEY Outcomes or if you are a site

and have questions regarding ODYSSEY

Outcomes please contact Robert Evans at

[email protected] or 1-800-707-9098

Option 1.

REGULATE PCI

CVC is buzzing with excitement on this long

awaited PCI trial, as we work to start up 20

centres across Canada and enroll over 13,000

patients globally in the next couple years.

Hats off to Dr. Warren Cantor and his

Study Coordinator Kim Robbins with the

York PCI Group in Newmarket, ON for

a record start up. They are not only the

first site activated in Canada but one of the

first 4 sites activated for the trial. Only a cou-

ple days after receiving study drug we are

pleased to share that they have already recruit-

ed 5 patients. Thanks to them and their team

at York PCI for all their hard work to make

this happen.

We have had a tremendous response from our

Canadian sites on this study and are now ac-

tively working through start-up with the plan

to have many of our Canadian sites activated

over the next couple months. If you are one of

our participating sites, we will be working with

you to ensure all ethics submissions are in by

mid-Oct. Please email your regulatory docu-

ments for review as they become completed.

We look forward to seeing some of our inves-

tigators and study coordinators next month in

Chicago for our first investigator meeting.

For further information, or if you are interest-

ed in participating, please contact Clinical Trial

Project Lead, Jodi Parrotta at 1-800-707-9098,

ext. 3 or by email at [email protected].

Sponsored by Regado

Biosciences Inc. this is a

randomized, open-label,

multi-center, active-

controlled, parallel group

study to determine the

efficacy and safety of the

REG1 Anticoagulation

System Compared to

Bivalirudin in Patients

Undergoing Percutaneous

Coronary Intervention

Clinical trials.gov



Volume 17, No. 2

TECOS

With the expected study end date on target

for the latter part of 2014, the pressure is on

to maintain or improve our patient retention

numbers and to clean up data!

Our Canadian TECOS sites have done an

excellent job of retaining patients in the study

and keeping our withdrawn consent or lost to

follow-up numbers low. We do, however,

need to be vigilant about the number of

patients permanently discontinuing study drug.

It is essential that Principal Investigators are

involved in any decision to discontinue study

drug and that these decisions are well-

documented at the site. You have put such

tremendous effort into the TECOS study over

the last several years we want to ensure that

the end result is meaningful!

The Inform data complete and clean rates in

Canada continue to be impressive at 98% to

99%. One of the main data priorities now as

we near the finish line is to ensure that data is

being entered in a timely manner after visits so

that the Project Team can keep a close eye on

patients that may be at risk for becoming lost

to follow-up. The other priority is to ensure

that CEC queries are being taken care of

quickly and thoroughly. TECOS is a

cardiovascular outcomes driven trial and will

continue until the required CV events have

been accrued . The Clinical Events Committee

must receive all of the appropriate information

– all required source documents provided and

requests for additional data needed, before

adjudication can be completed. We can’t do

this without your help!

Congratulations to the following sites that

have 100% clean data!

Dr. Sigalas & Darlene Hutton – Rouge

Valley Metabolic Research Associates,

Scarborough, ON

Dr. Yale & Mylene Roy – Royal Victoria

Hospital, Montreal, QC

Dr. Saunders & Lori Richert – Rivergrove

Medical Clinic, Winnipeg, MB

A TECOS rejuvenation meeting is in the

planning stages and will likely occur this

November. Please keep an eye out for further

communications coming via email in the near

future.


Trial Project Lead, Lyndsey Garritty at

1-800-707-9098, ext 4 or via email at

[email protected].

Sponsored by Merck & Co.

Inc., TECOS is a

Randomized, Placebo

Controlled Clinical Trial to

Evaluate Cardiovascular

Outcomes after Treatment

with Sitagliptin in Patients

with Type 2 Diabetes

Mellitus and Inadequate

Glycemic Control.

ClinicalTrials.gov


GUIDE-IT

In collaboration with DCRI

(Duke Clinical Research

Institute) GUIDE-IT is a

prospective, randomized

1:1, multi-centre clinical

trial GUIDing Evidence

Based Therapy Using

Biomarker Intensified

Treatment in Heart Failure

ClinicalTrials.gov


GUIDE-IT is just getting warmed up after the

summer months. The first Canadian site has

been activated and we look forward to the

first patient being enrolled momentarily with

many more to come! Congratulations to our first active site!

Dr. Patricia Campbell, Kim Ronak and

Sheilah Heal at University of Calgary/

Foothills Hospital in Calgary, Alberta.

Site Initiation Visits are complete and lab kits

have arrived on site, so with only a few site-

specific regulatory items outstanding we are

projecting that the remainder of our Canadian

sites will be ready to enroll within weeks. The

U.S. has enrolled over 80 patients and Canada

is eager to contribute to this number over the

coming months.

Protocol Amendment 1 has been distributed

and for those sites that are still in the ethics

review stages for this amendment, please re-

member that waivers for the revised patient

eligibility criteria are available if required.

The GUIDE-IT website is an invaluable re-

source for study documents and materials,

training and education items, study updates

and frequently asked questions. Please don’t be

shy about accessing this tool when needed!

Thank you to all of our GUIDE-IT sites for

your commitment to participate in this im-

portant heart failure study. We are looking

forward to working with each of you closely to

make this trial a success!


Trial Project Lead, Lyndsey Garritty at

1-800-707-9098, ext 4 or via email at

[email protected].




Monitoring

While we often cringe when we hear the word

“audit” cross our path, we have also come to

realize that with each audit we are involved in

we learn new things and become better at

what we do. We are always keen to share

these insights with you and hope that you can

implement some, if not all of them, into your

organizations now rather than when the

auditor dials up your number. Here are a few

tips to implement into your practice so you

are ready for that next audit:

Ensure all staff participating in the study at

your site are trained on (1) the protocol,

(2) any amendments, (3) GCP and Health

Canada Division 5, (4) transportation of

dangerous goods, (5) specimen collection,

and any other trial specific processes

prior to performing study procedures.

Ensure you have certificates and

documentation for each staff member

who will be working on the trial and make

sure that the trainer at your site is the

one documenting the topics of discussion

and not the trainee. All training should be

current.

In addition to having site SOP’s, for each

study that you participate in you should

have documented processes that are

specific for that trial. For example, if study

drug is required to be refrigerated, what

is your process once the drug is delivered

to your office, what is the process that

you will follow for temperature

excursions, and what is the process in the

event of a power outage? Other

processes can include things like where

are subjects going to be seen in the clinic,

and how will blood specimens be handled

and shipped.

Ensure you have calibration and

maintenance documentation of equipment

such as thermometers, blood pressure

machines, scales, ECG’s, centrifuge, etc.

Keep all records and make sure your

calibration and maintenance documents

are current.

Whether you work in a hospital or clinic

and have electronic medical records, you

should have validation documentation that

includes how often it is validated as well

as how and when the records are backed

up and stored.

CVC News

The CVC would like to welcome and

introduce you to our new team members:

Amanda Carapellucci

joined the CVC in

August to fill in as

Project Lead on the

EXSCEL trial during

Courtney Gubbels

maternity leave. Her

background includes a

BSc in Biological

Sciences and several

years of experience in research administration

and oncologic clinical trials.

Yvonne Regnier joined

CVC in August as

Dr. Armstrong's

Executive

Assistant. Yvonne has

extensive senior level

office administration

experience in both the

private and public

sector, as well as

diverse editorial experience in the research

arena in the Human Nutrition Research

Group at the University of Alberta.

Kalli Belseck joined the

CVC team back in

June, filling the role as

our Administrative

Assistant. She is a

recent graduate with a

BA, majoring in

Anthropology. Kalli is

becoming more

involved with the

clinical operations team and will be supporting

them on the trials with her initial focus on

PROACT, IMPROVE-IT and REGULATE PCI.

New Concepts in

Acute Coronary

Syndromes

Presenters:

• Paul Armstrong, MD

• Frans Van de Werf, MD

• Robert Welsh, MD

• Christopher Buller, MD

• Shaun Goodman, MD

• Valerie Desjardins, MD

• Darren McGuire, MD

• Justin Ezekowitz, MD

Agenda:

• The Future of ST

Elevation Myocardial

Infarction Care: One Size

Does Not Fit All

• The Need for Rescue

PCI After Failed

Fibrinolysis: Who, When

and Why?

• Modulating the

Oculogyric Reflex in

Acute Coronary

Syndromes: Insights from

a Veteran

• Triple Antithrombotic

Therapy in ACS:

Navigating the Quagmire

• Diabetes and Acute

Coronary Syndromes: An

Evidence-based Approach

• Acute Heart Failure –

ACS in Wolves’ Clothing?

Challenges and

Opportunities

• The Future of Clinical

Trials in ACS: More with

Less?

With monitoring related questions please

contact Lead CRA, Halina Nawrocki at 1-905-

896-7292 or by email at ha-

[email protected].

Volume 17, No. 2

Selected CVC Presentations and Publications Since Last Issue

Leonardi S, Tricoci P, White HD, Armstrong PW,

Huang Z, Wallentin L, Aylward PE, Moliterno DJ,

Van de Werf F, Chen E, Providencia L, Nordrehaug

JE, Held C, Strony J, Rorick TL, Harrington RA,

Mahaffey KW. Effect of Vorapaxar on Myocardial

Infarction in the Thrombin Receptor Antagonist for

Clinical Event Reduction in Acute Coronary Syn-

drome (TRA•CER) Trial.Eur Heart J 2013; 34 (23):

1723-31. http://dx.doi.org/10.1093/eurheartj/eht104.

Rose JJ, Newby LK, Broderick S, Chiswell K, Van de

Werf F, Armstrong PW, Mahaffey KW, Harrington

RA, Ohman EM, Giugliano RP, Goodman SG,

White HD, Califf RM, Granger CB, Lopes RD. Left

bundle branch block in non-ST segment elevation

acute coronary syndromes: incidence, angiographic

characteristics and clinical outcomes. J Am Coll Cardi-

ol. 2013; 13: 1461–1463. http://dx.doi.org/10.1016/

j.jacc.2012.12.032 (Letter to Editor).

Guptill JT, Mehta RH, Armstrong PW. Horton J,

Laskowitz D, James S, Granger CB, Lopes RD.

Stroke After Primary Percutaneous Coronary Inter-

vention in Patients With ST-Segment Elevation My-

ocardial Infarction: Timing, Characteristics, and

Clinical Outcomes (APEX-AMI) Circ Cardiovasc In-

terv. 2013;6: 176-83. http://dx.doi.org/10.1161/

CIRCINTERVENTIONS.112.000159.

Lopes RD, White JA, Atar D, Keltai M, Kleiman NS,

White HD, Widimsky P, Zeymer U, Giugliano RP,

Tricoci P, Braunwald E, Bode C, Ohman EM, Arm-

strong PW, Newby LK. Incidence, treatment, and

outcomes of atrial fibrillation complicating non-ST-

segment elevation acute coronary syndromes. Int J

Cardiol. 2013 Apr 8. http://dx.doi.org/ 10.1016/

j.ijcard.2013.03.037 (online publication).

Klutstein MW, Westerhout CM, Armstrong PW,

Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S,

Widimsky P, Steg PG, Dalby A, Zeymer U, Van de

Werf F, Harrington RA, Newby LK, Rao SV. Radial

versus femoral access, bleeding and ischemic events

in patients with non-ST-segment elevation acute

coronary syndrome managed with an invasive strat-

egy. Am Heart J. 2013 Apr;165(4):583-90. http://

dx.doi.org/10.1016/j.ahj.2013.01.009. Epub 2013 Feb

22.

Kaul P, Ezekowitz JA, Armstrong PW, Leung BK,

Savu A, Welsh RC, Quan H, Knudtson ML, McAl-

ister FA. Incidence of heart failure and mortality

after acute coronary syndromes. Am Heart J.

2013;165(3):379-85. http://dx.doi.org/10.1016/

j.ahj.2012.12.005.

van Diepen S, Newby LK, Lopes RD, Stebbins A,

Hasselblad V, James S, Roe MT, Ezekowitz JA,

Moliterno DJ, Neumann FJ, Reist C, Mahaffey KW,

Hochman JS, Hamm CW, Armstrong PW, Granger

CB, Theroux P; on behalf of the APEX AMI Investi-

gators. Prognostic relevance of baseline pro- and

anti-inflammatory markers in STEMI: An APEX

AMI substudy. Int J Cardiol. 2013 Feb 7. http://

dx.doi.org/10.1016/j.ijcard.2013.01.004 [Epub

ahead of print].

Tricoci P, Leonardi S, White J, White HD, Arm-

strong PW, Montalescot G, Giugliano RP, Gibson

CM, Van de Werf F, Califf RM, Harrington RA,

Braunwald E, Mahaffey KW, Newby LK. Cardiac

Troponin after Percutaneous Coronary Interven-

tion and 1-Year Mortality in NSTE ACS Using Sys-

tematic Evaluation of Biomarker Trends. J Am Coll

Cardiol. 2013; 62(3); 242–251. http://

dx.doi.org/10.1016/j.jacc.2013.04.043.

Lopes RD, Lokhnygina Y, Hasselblad V, Newby KL,

Yow E, Granger CB, Armstrong PW, Hochman JS,

Mills JS, Ruzyll W, Mahaffey KW. Methods of crea-

tine kinase-MB analysis to predict mortality in pa-

tients with myocardial infarction treated with

reperfusion therapy. Trials 2013, 14:123 epublica-

tion http://www.trialsjournal.com/

content/14/1/123; (PMID 23782531) http://

dx.doi.org/10.1186/1745-6215-14-123.

Nicolau JC, Corbalan R, Rafael Diaz R, Bahit C,

Armstrong PW, Granger CB, Lopes RD. Cardio-

vascular clinical research in South America. Am

Heart J 2013;165:848-53. http://dx.doi.org/10.1016/

j.ahj.2013.02.004.

Bahit MC, Lopes RD, Clare RM, Newby LK, Pieper

KS, Van de Werf F, Armstrong PW, Mahaffey KW,

Harrington RA, Diaz R, Ohman M, White HD,

James S, Granger CB. Heart Failure Complicating

Non–ST-Segment Elevation Acute Coronary Syn-

drome: Timing, Predictors, and Clinical Outcomes.

J Am Coll Cardiol HF 2013;1:223–9. http://

dx.doi.org/10.1016/j.jchf.2013.02.007.

Zannad F, Garcia AA, Anker SD, Armstrong PW,

Calvo G, Cleland JGF, Cohn JN, Dickstein K, Do-

manski MJ, Ekman I, Filippatos GS,Gheorghiade M,

Hernandez AF, Jaarsma T, Koglin J, Konstam M,

Kupfer S, Maggioni AP, Mebazaa A, Metra M,

Nowack C, Pieske B, Piña IL. Pocock SJ, Piotr Poni-

kowski P, Rosano G, Ruilope LM, Ruschitzka F,

Severin T, Solomon S, Stein K, Stockbridge NL,

Stough WG, Swedberg K, Tavazzi L, Voors AA,

Wasserman SM, Woehrle H, Zalewski A, McMur-

ray JJV. Clinical outcome endpoints in heart failure

trials: a European Society of Cardiology Heart

Failure Association consensus document. Eur J

Heart Fail. Epublication (PMID: 23787718) http://dx.doi.org/10.1093/eurjhf/hft095.

Alherbish A, Westerhout CM, Fu Y, White HD,

Granger CB, Wagner G, Armstrong PW. The For-

gotten Lead: Does aVR ST-deviation Add Insight

into the Outcomes of STEMI Patients? Am Heart J

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http://dx.doi.org/10.1093/eurjhf/hft095

Address for Inquiries or

Submission of Articles of

Interest:

2-132 Li Ka Shing Centre for

Health Research Innovation

University of Alberta

Edmonton, AB T6G 2E1

Canada

Phone: 1-800-707-9098

Fax: (780) 492-0613

www.vigour.ualberta.ca

CANADIAN VIGOUR CENTRE

Articles Continued...

Publication Information

This newsletter is published periodically as a service to Canadian investigational sites. The

purpose is to provide information of interest to individuals involved in cardiovascular clinical trials

managed by the Canadian VIGOUR Centre, University of Alberta in Edmonton, Alberta, Canada.

The VIGOUR (Virtual Coordinat-ing Centre for Global Collabora-tive Cardiovascular Research)

group is an international academic group committed to advancing cardiovascular medicine and enhancing patient care worldwide.

Its membership includes: the Canadian VIGOUR Centre (CVC), University of Alberta, Edmonton,

Alberta, Canada; Green Lane Coordinating Centre, Auckland, New Zealand; National Health &

Medical Research Council – Clinical Trials Centre, Sydney, Australia; Flinders Medical

Centre, Bedford Park, Australia; Duke Clinical Research Institute

(DCRI), Duke University, Durham,

NC, USA; Leuven Coordinating Centre, University Hospital Gasthuisberg, Leuven, Belgium; ECLA, Rosario, Argentina, South

America; TANGO, Buenos Aires, Argentina, South America; Uppsala Clinical Research Centre, Uppsala,

Sweden

Acknowledgments to our Sponsors:

Alere Inc.

Amylin Pharmaceuticals, LLC

GlaxoSmithKline Inc.

Hoffmann-La Roche

Merck & Co.,Inc. Regado Biosciences Inc.

Sanofi-aventis Recherche & Développement

Canadian Cardiac Chronicle Editorial Board:

PW Armstrong

Kalli Belseck

Courtney Bryden

Amanda Carapellucci

Robert Evans

Lyndsey Garritty

Halina Nawrocki

Jodi Parrotta

Dianne Payeur

Paula Priest

Tracy Temple

2013; 166: 333-9. (PMID: 2389517) http://

dx.doi.org/10.1016/j.ahj.2013.05.018.

Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong

PW, Starling RC, McMurray JJ, Massie BM, Swed-

berg K, Ezekowitz JA, Fonarow GC, Teerlink JR,

Metra M, Whellan DJ, O’Connor CM, Califf RM,

Hernandez AF Do Countries or Hospitals With

Longer Hospital Stays for Acute Heart Failure

Have Lower Readmission Rates? Findings From

ASCEND-HF. Circ Heart Fail. 2013;6:727-732.

http://dx.doi.org/10.1161/

CIRCHEARTFAILURE.112.000265 ( Editor’s

Pick).

Roe MT, Goodman SG, Ohman EM, Stevens SR,

Hochman JS, Gottlieb S, Martinez F, Dalby AJ,

Boden WE, White HD, Prabhakaran D, Winters

KJ, Aylward PE, Bassand JP, McGuire DK, Ar-

dissino D, Fox KA, Armstrong PW. Elderly Pa-

tients with Acute Coronary Syndromes Managed

Without Revascularization: Insights into the Safe-

ty of Long-Term Dual Antiplatelet Therapy with

Reduced-Dose Prasugrel versus Standard-Dose

Clopidogrel. Circulation. 2013 2013;128:823-33.

(PMID: 23852610) http://dx.doi.org/10.1161/

CIRCULATIONAHA.113.002303.

Howlett JG, Ezekowitz JA, Podder M, Hernandez

AF, Diaz R, Dickstein K, Dunlap ME, Corbalán R.

Armstrong PW, Starling RC, O’Connor CM,

Califf RM, Fonarow GC; on behalf of the AS-

CEND-HF Investigators Global Variation in Qual-

ity of Care Among Patients Hospitalized With

Acute Heart Failure in an International Trial Find-

ings From the Acute Study Clinical Effectiveness

of Nesiritide in Decompensated Heart Failure

Trial (ASCEND-HF). Circ Cardiovasc Qual Out-

comes. 2013;6: on line publication http://

dx.doi.org/10.1161/

CIRCOUTCOMES.113.000119.

van Diepen S, Vavalle JP, Newby LK, Clare R,

Pieper KS, Ezekowitz JA, Hochman JS, Mahaffey

KW, Armstrong PW, Granger CB. The Systemic

Inflammatory Response Syndrome in Patients

With ST-Segment Elevation Myocardial Infarction.

Crit Care Med. 2013 Jun 11. [Epub ahead of print] PMID:23760155.

Wiviott SD, White HD, Ohman EM, Fox KAA,

Armstrong PW, Prabhakaran D, Hafley G, Lokh-

nygina Y, Boden WE, Hamm C, Clemmensen P,

Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P,

Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for

patients with unstable angina or non-ST-segment

elevation myocardial infarction with or without

angiography: a secondary, prespecified analysis of

the TRILOGY ACS trial. Lancet 2013;382:605-13

(PMID:23953385) http://dx.doi.org/10.1016/

S0140-6736(13)61451-8.

"Notice the outer ring of the compass is framed by

four phrases we believe capture the context of our work; (i) leading hearts and minds which links with our

logo of “bridging” hearts and minds, reflecting our

earnest efforts to provide thought leadership to

research so as to maximize its impact to

cardiovascular patients (ii) continuously innovating or

exploring new paths to enhance the care of our

patients but also finding new and better way of doing

things (iii) ensuring our work has impact on the

cardiovascular health and on health policy and (iv)

career development of our most valuable resource,

namely our people. Now working from inside the

compass, our purpose is central, and as equally well

known are CVC’s vision and core values, which were

the product of a prior Advance, and remain steadfast

and relevant today. The two new quadrants are

occupied by our promise which is what commitments

we aim to keep in fulfilling our purpose and finally

what operational priorities we propose moving

forward."











cvc chronicle fall 2013

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