the association between point-of-care testing of troponin
TRANSCRIPT
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The association between Point-of-Care testing of Troponin and the management of patients with chest pain suspected of acute coronary syndrome: a systematic review protocol
Fen Li, RN, BNg, ICUCert, Dip Crit Care, MN1
Robyn Clark, RN, RM, ICUCert, Dip AppliSci, BN, Med, PhD, ACCCN (Life Member), FCNA, FAHA,
PhD1,3
Vincent Versace, BSc, PhD2
Peter Newman, BBs, Dip IT1
1.School of Nursing and Midwifery, Flinders University, South Australia
2.Greater Green Triangle University, Department of Rural Health, Flinders University and Deakin
University, Australia
3. Centre for Evidence-based Practice South Australia: a collaborating centre of the Joanna Briggs
Institute
Corresponding author
Fen Li,
Review question/objective
The objective of this review is to investigate the association between Point-of-Care testing of Troponin
(PoCT-cTn) and the management of chest pain patients suspected of Acute Coronary Syndrome
(ACS), including timely diagnosis and triage, time to percutaneous coronary intervention (PCI) or
fibrinolysis, and length of stay in the Emergency Department (ED).
Background
Cardiovascular diseases are defined by the World Health Organisation (WHO) as ‘a group of disorders
of the heart and blood vessels’, which include coronary heart disease (acute coronary
syndrome),cerebrovascular disease (stroke), peripheral arterial disease, rheumatic heart disease,
congenital heart disease, deep vein thrombosis and pulmonary embolism.1
Acute coronary syndrome (ACS) is caused by athero-thrombotic lesions of heart that are associated
with a thrombus formation on a ruptured atherosclerotic plaque, leading to a reduction in the supply of
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oxygen and nutrients to the heart muscle and impairing cardiac functions, presenting acute myocardial
infarction (AMI).2
ACS reflects the spectrum of coronary artery disease (CAD) resulting in acute myocardial ischemia
and includes unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI) and
ST-segment elevation myocardial infarction (STEMI).3 They can be distinguished as per their
definitions defined by the Global Registry of Acute Coronary Events (GRACE) (Table 1).4
Table 1: Definitions of the spectrum of acute coronary syndrome
Spectrum of ACS Definition
UA ‘no positive enzyme findings of suspected ACS’
NSTEMI ‘no new ST-elevation seen on the index or on any subsequent ECG, with one or more positive cardiac enzymes, based on laboratory ranges in use at each hospital’
STEMI ‘new or presumed new ST-elevation >1 mm seen in any location on the index ECG or on any subsequent ECG, together with one or more positive enzymes, based on laboratory ranges in use at each hospital’
Clinically these diagnoses encompass a wide variation in risk, requiring complex and timely risk
stratification and representing a large social and economic burden. According to the World Health
Organization, ACS claims 17 million lives every year.5 It has been and will continue to be the single
leading cause of death.
Typical symptoms of acute ACS/MI include, but are not limited to, sudden retrosternal chest pain
(usually radiating to the left arm, left side of the neck, or abdomen) with shortness of breath, nausea,
vomiting, palpitations, sweating, anxiety and sudden death, with no precursor signs.6 However, a
sizeable proportion of myocardial infarctions (22–64%) are ‘silent’, that is without chest pain or other
symptoms.7 This has brought challenges to the diagnostic issues of AMI. Typically, the
electrocardiogram (ECG) provides unique and important diagnostic information to distinguish STEMI
and NSTEMI acute coronary syndromes. In the spectrum of ACS, UA/NSTEMI usually presents by
chest pain, ECG with no ST-segment elevation but ST-segment depression or prominent T-wave
inversion and/or positive biomarkers of necrosis (e.g. troponin).8
However, hyperacute T wave change on ECG may mislead diagnosis due to non-cardiac causes (e.g.
hyperkalaemia, renal failure).9 If the patient has chest pain without ST-segment elevation on the ECG,
the measurement of cardiac Troponin (cTn) becomes the cornerstone of ACS diagnosis.10
Introduction of point-of-care testing of Troponin
Only two thirds of chest pain patients (66%) presented to hospitals, responsible for emergency hospital
admissions, and the main reason for hospital attendance could be the possibility of acute myocardial
infarction (AMI).12
Among the chest pain patients, half of presentations (46%) had chest pain with
unlikely ischemic chest pain or ACS, but one third of them (33%) experienced MI, and one fifth (21%)
of them had unstable angina or likely ischemic chest pain.12
To distinguish different spectrums of ACSs
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and non-cardiac cases and to do appropriate risk stratification and triage, current guidelines of ACS
require a troponin sample taken on arrival or at least 6 hours after the onset of chest pain.13
Troponin is a complex of three regulatory proteins (Troponin C, Troponin I and Troponin T) that is
integral to muscle contraction in skeletal and cardiac muscles, but not in smooth muscles.14
Troponin C
has identical form in skeletal muscles, therefore, it has not been used as a cardiac marker of
myocardial ischaemia.9 Troponin I (cTn I) and Troponin T (cTn T) have been the focus of studies to
determine diagnostic values in detecting cardiac injury or infarction since the late 1980s.15,16
They are
very sensitive and specific indicators of damage to the myocardium. When heart damage has
occurred, the proteins are released into the blood stream and can be measured in a blood sample,
especially when having ‘heart attack’.17
Previously, Creatinine Kinase (CK) was preferred for diagnosis of ACS.18
In the past decade, cardiac
Troponin (cTn) has emerged as a preferred choice over CK for the diagnostic need of ACS/AMI in
chest pain patients. Cardio-specific enzyme Troponin I and Troponin T are not detectable in healthy
people. Any elevation in cTn levels indicates some degree of myocardial necrosis. Therefore, cTn has
become a gold standard cardiac marker (CM) of MI due to its high diagnostic specificity and prognostic
value in the clinical setting.18,19
However, cTn is time dependent and needs to be detected within a few hours of chest pain onset.
Point-of-Care testing of Troponin (PoCT-cTn) is a rapid test and practical in clinical settings.
Point-of-Care Testing (PoCT) is defined as testing conducted at or near the site of patient care,
allowing blood samples to be processed immediately.20
Point-of-Care testing of Troponin refers to
PoCT for a rapid assay for cTn values, via doing finger pricks and testing on portable platforms. It can
provide rapid results of cTn with turnaround times as short as 15-30 minutes in comparison with
laboratory testing needing 60-90 minutes.21
PoCT-cTn can significantly reduce the turnaround time
from testing to results, allowing more immediate patient triage and effective management.21
Evidence based management of ACS
The American College of Cardiology (ACC) states that the cTn result should be available within 60
minutes of presentation and preferably within 30 minutes.22
PoCT-cTn has been highly recommended
and subsequently included in ACS guidelines, specifically where the timely management of the
condition is the focus. It is important for NSTEMI patients presenting with chest pain, who should be
diagnosed and assigned to a risk group as rapidly as possible.23
Relevant guidelines include the
guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA),24
the European Society of Cardiology’s guidelines,23,25
the Guidelines for the management of ACS
generated in 2006 by the National Heart Foundation of Australia (NHFA) and the Cardiac Society of
Australia and New Zealand (CCANZ),18
and its Addendum enacted in 2011.13
According to the above evidence, chest pain patients who are suspected of ACS should have a
comprehensive initial assessment to screen the risk of ACS, including collecting a medical history,
performing a physical examination and recording risk factors. Initial management includes a 12 lead
ECG and Troponin testing. If ECG presents ST segment elevation ≥1mm (STEMI) with or without
Troponin changes, the patient is managed by the high risk pathway. However, if the patient’s ECG is
negative (NSTEMI), then Troponin values are significant to classify patients. If cTn is positive (above
the 99th percentile or > 20% rise/fall of baseline by high sensitivity testing), MI is likely to be diagnosed
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and the patient will be managed with the moderate risk/high risk pathway, seeking cardiac consultation
and further investigation. If a negative result is present, ACS is unlikely and treatment may proceed to
early ‘rule-out’ CAD testing (e.g. stress ECG).13
Otherwise, the patient will be classified as low risk, and
if there is no ongoing chest pain and hospitalization is not required, the patient can be discharged
home.8, 26, 27
The national guidelines of ACS of Australia require that every chest pain patient suspected of ACS
should perform cTn testing (high sensitivity) on arrival to the ED to ‘rule in’ ACS within the differential
diagnosis in cTn level.13
In order to promptly rule in or rule out the risk of ACS, PoCT-cTn should be
implemented if the high sensitivity cTn result is not available within 60 minutes. Although PoCT-cTn is
not based on the new high sensitivity testing, it should be used to ensure timely risk assessment when
likely substantial delay in cTn assays will occur.13
The thresholds of positive cTn values were reduced with technical development on the cTn assays.
They were 1.5ng/ml defined in 1995, changed to1.0ng/ml in 2004 and further decreased to 0.04ng/ml
since 2007.28
The positive value of acceptable accuracy for the diagnosis of AMI was defined as >99th
percentile (equal to 0.04 mg/L), either doing serial specimens at least three hours apart or one
specimen at least six hours from the onset of symptoms,29
which is sufficient to provide high accuracy
for ruling out MI.13
If no high sensitivity testing is available, the diagnosis of MI requires both an
elevation of troponin levels above the 99th percentile and a >20% change (rise and/or fall) when using
older troponin assays, informed by recent consensus guidelines.30-32
The effects of PoCT-cTn
Point-of-care testing of Troponin is usually performed at the bedside by ED staff. The best use of the
result of Point-of-Care testing depends on clinicians who are prepared to act on the test results
immediately.33
Optimal outcomes in chest pain patients rely on rapid diagnosis, accurate risk
stratification and the effective implementation of evidence-based therapies, as advocated by clinical
guidelines. This goal is reachable but the challenge is in effectively applying evidence in clinical
practice and in understanding the evidence–practice gap that is objective and needs standardized
quantification of clinical practice.
It has been verified that PoCT-cTn rapidly provides a blood test of the Cardiac Enzyme of Troponin
(cTn), being the gold standard of diagnosing ACS.18,19
It can be used to rule out and rule in ACS,
thereby facilitating effective treatment of ACS patients.13
In a report from South Australia, PoCT-cTn
benefited rural and remote areas where they did not have an on-site laboratory, and had to wait up to
36 hours to receive pathology results.34
PoCT-cTn was identified as a critical enabler for improving
patient management in rural and remote areas.34
Conversely, the negative reports were found on the utilization of PoCT-cTn. Five studies opposed the
utilization of PoCT-cTn in the ED and cardiac short-stay units.35-39
Two studies opposed the application
of PoCT-cTn in the pre-hospital setting,40,41
and one opposed the utilization of PoCT-cTn in the
outpatient clinic setting.42
In a large study performed by Takakuwa et al., on Point-of-care testing in ED patients suspected of
ACS showed that of 568 hospitals and of 67,058 patients, differences existed in how hospitals utilized
PoCT–cTn and the resultant intervention provided. High PoCT–cTn usage hospitals were less likely to
give aspirin, β-blockers and heparin within the first 24 hours of admission. Patients with positive PoCT–
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cTn had fewer electrocardiograms within 10 minutes, but were more likely to be administered aspirin,
β-blockers, glycoprotein IIb/IIIa inhibitors and heparin within 24 hours of arrival. They received fewer
in-hospital and interventional procedures and had more adverse clinical events. This study showed
negative outcomes of PoCT–cTn technology in triage and risk stratification of chest pain patients.43
In general, PoCT-cTn has been advocated by the guidelines for ACS and some studies have informed
positive outcomes in clinical practice from its utilization. Within the literature, negative findings were
also reported, yet there is no systematic review looking into whether PoCT-cTn improves the
evidence-based practice (EBP) of chest pain patients suspected of ACS either in tertiary hospitals or
country hospitals. Therefore, this review will be performed to pool evidence regarding the effect of
PoCT-cTn on chest pain patients, determining the association of PoCT-cTn and the management of
chest pain suspected ACS patients, focusing on timely diagnosis and triage, time to percutaneous
coronary intervention (PCI) or fibrinolysis and length of stay in the ED.
Keywords
Chest pain, Acute coronary syndrome (ACS), Point-of-Care testing, Troponin, Diagnosis, Evidence
based practice, Triage, Risk stratification, Length of stay, Cardiac pain, Heart Pain, Myocardial
Infarction and Heart attack.
Inclusion criteria
Types of participants
Chest pain patients (no age limits) presenting to the ED or outpatient clinics, regardless of
geographical locations (metropolitan or rural and remote).
Types of intervention:
This review will consider studies that investigate the use of the PoCT-cTn alone or in combination with
other testing evaluating timely diagnosis of ACS, triage and risk stratification, intervention decision
making and length of stay in the ED, either in routine clinical practice or in intervention trials.
Comparator:
Clients who were not provided with rapid PoCT-cTn.
Types of outcomes
Primary outcomes:
Compliance with the management of guidelines of ACS
Time to triage/risk stratification of chest pain /ACS and time in the ED
Secondary outcomes:
Diagnostic accuracy of a point-of-care troponin
The proportion of patients successfully discharged home
Mortality of ACS
Types of studies
This review will consider published quantitative studies having experimental and epidemiological study
designs, including randomized controlled trials (RCTs), non-randomized controlled trials,
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quasi-experimental, before and after studies, prospective and retrospective cohort studies,
case-control studies and analytical cross-sectional studies, which evaluate the effect of PoCT-cTn.
Search strategy
The search strategy aims to find peer-reviewed published studies. A three-step search strategy for
databases will be used and has been adapted from the Joanna Briggs Institute Reviewers’ Manual
(2011 edition) guidelines : (1) a limited search of MEDLINE and CINAHL will be undertaken followed
by analysis of text words in the title and abstract, and of the index terms used to describe the article;
(2) searching across all databases using all identified key words and index terms; (3) searching the
reference lists of all identified reports and articles for additional studies.44
Studies published in English
and up to August 2014 will be considered for inclusion in this review.
The databases to be searched include CINAHL, MEDLINE, EMBASE, the Web of Knowledge,
PubMed, Cochrane Library, ProQuest, JBI, Web of Science, Google Scholar, AgeINFO (for literature
related to older people), and the reference lists of included articles to find any other relevant studies. If
there is any unclear information from the articles, an attempt will be made to contact authors for further
information.
To ensure a broad range of research is reviewed, the search will also include the following websites:
http://www.ncbi.nlm.nih.gov/
http://www.nhmrc.gov.au/nics/asp/index.asp;
http:trove.nla.gov.au
http://www.sciencedirect.com
All studies retrieved will be screened and the full text of studies that potentially meet the inclusion
criteria will be obtained.45
Final decisions will be made after reading the full-text of articles.
Exclusion criteria
This review will exclude all unpublished studies (there should be caution when including them in
summaries of the evidence), due to unpublished studies commonly showing discrepancies between
abstract results and subsequent full-length publication results.46
Also, this review will exclude
publications that were published in languages other than English as no facilities are available for
translation needs. Furthermore, this review will exclude all qualitative studies on this topic as the aim of
this study is to evaluate the effectiveness of PoCT-cTn.
The search terms to be used will include:
The initial terms are to be used and include chest pain, acute coronary syndrome and Point-of-Care
testing of Troponin. Following the initial search, more terms are to be applied including: chest pain,
acute coronary syndrome; coronary syndrome, acute, syndromes, acute coronary, myocardial infarct,
acute myocardial infarction, myocardial ischemia, coronary artery disease, cardiovascular disease,
bedside testing, point-of-care systems, Troponin, Troponin I, Troponin T, Point-of-Care testing of
Troponin, clinical laboratory techniques, biological markers, diagnosis, evidence based practice,
triage, risk stratification, and length of stay.
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Assessment of methodological quality
All quantitative papers on PoCT-cTn in chest pain/ACS patients selected for retrieval will be assessed
by two independent reviewers for methodological validity prior to inclusion in the review using
standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics
Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise
between the reviewers will be resolved through discussion, or with the third reviewer.
Data collection
Data will be extracted from individual studies. Information on the characteristics of participants,
interventions and outcomes will be recorded on a standardized data extraction tool from JBI-MAStARI
(Appendix II). In addition, aspects of trial methods will be categorized as RCTs (methods of RCTs and
their allocation concealment, use of blinded outcome assessment, intention-to-diagnosis and
intention-to-triage, reporting of ACS patient management outcomes), non-randomized controlled trials,
quasi-experimental, before and after studies, prospective and retrospective cohort studies,
case-control studies and analytical cross sectional studies. The data extracted will include specific
interventions, populations, study methods and outcomes of significance to the review question and
specific objectives. If this is insufficient for analyzing variations of data, subgroup data of settings (ED,
outpatient clinics) and populations (aged <65 and aged ≥ 65) will be considered.
Data synthesis
Quantitative papers will, where possible, be pooled in statistical meta-analysis using the Joanna Briggs
Institute Meta-Analysis of Statistics Assessment and Review Instrument. Odds ratios (for categorical
data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be
calculated for analysis. Heterogeneity will be assessed using the standard Chi-square. Where
statistical pooling is not possible, the findings will be presented in narrative form.
Conflicts of interest:
No conflict of interest is known.
Acknowledgements
No external funding is involved in this review.
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Fen Li
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Appendix I: Appraisal instruments
MAStARI appraisal instrument
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Appendix II: Data extraction instruments
MAStARI data extraction instrument
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