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Optimum Troponin Cutoffs for ACS in the ED (ROMI-3)

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ClinicalTrials.gov Identifier: NCT01994577
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
McMaster University ( Canadian Institutes of Health Research (CIHR) )

Tracking Information
First Submitted Date November 19, 2013
First Posted Date November 26, 2013
Last Update Posted Date July 26, 2018
Study Start Date May 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2013)
Composite Outcome [ Time Frame: 7, 30, and 180 days ]
We have chosen a composite outcome that includes cardiovascular death, MI, serious ventricular cardiac dysrhythmia, hospital admission for decompensated congestive heart failure, and hospital admission for refractory cardiac ischemia following ED discharge at 7, 30 and 180 days based on our understanding and previous assessment of the strengths and limitations of composite endpoints, expert consensus opinion and our previous biomarker research.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optimum Troponin Cutoffs for ACS in the ED
Official Title Determining the Optimum Treatment Cutoffs for Cardiac Troponin Assays in Patients Presenting to the Emergency Department With Suspected Cardiac Ischemia
Brief Summary Blood tests may be able to quickly identify and exclude patients that are having a heart attack. Using these tests in the Emergency Department (ED) may lead to faster treatment, a reduced wait time, and quicker discharge for patients presenting with symptoms suggestive of a heart attack.
Detailed Description

Myocardial ischemia is a reduction in coronary blood flow insufficient for heart cell (myocardiocyte) demand. Prolonged ischemia results in myocardiocyte injury, death and necrosis i.e., myocardial infarction (MI). Cardiovascular disease resulting in myocardial ischemia is a major cause of morbidity and mortality worldwide. Acute coronary syndrome (ACS) is a spectrum of clinical presentations of acute myocardial ischemia ranging from ST-elevation MI (STEMI) to non-STEMI (NSTEMI) and unstable angina (UA). Because ACS portends a high-risk of death, treatment is time sensitive and delays to diagnosis and definitive care may decrease survival. However, the treatment-associated risk of bleeding, stroke and death also necessitate an accurate diagnosis of ACS.

Chest pain is the most common symptom of ACS and is the main cause of emergency department (ED) visits by the middle-aged and the second most common presenting complaint in other age groups accounting for up to 500,000 ED visits in Canada and 5 million in the United States of America (USA) each year. In 2005, the number of ED visits for chest pain increased by 20% over the previous decade and, as the median age of the western world's population increases over the next decade, EDs will assess more chest pain patients for ACS than ever before.

Because chest pain is a common presenting complaint and a symptom of many non-ACS conditions, the diagnosis of ACS is challenging. STEMI is diagnosed by specific electrocardiogram (ECG) findings whereas NSTEMI and UA are clinically indistinguishable because of the similarity in symptoms and transient or non-specific ECG findings at presentation. Differentiation of NSTEMI from the less severe UA is based on whether the ischemic myocardial injury is severe enough to release detectable concentrations of a myocardiocyte-specific protein, cardiac troponin (cTn). Therefore, patients with ACS symptoms and a non-diagnostic ECG are diagnosed with NSTEMI if their troponin level is above the cutoff concentration while similar patients with troponin levels below the cutoff are diagnosed with UA but both are admitted for treatment. However, patients with atypical symptoms with cTn concentrations below the cutoff represent a clinical dilemma and are usually discharged from the ED without any treatment or understanding of their risk of an ACS-related event within the next days, weeks or months.

Within the next year, many Canadian laboratories will replace their current cTn tests with the new high-sensitivity cardiac troponin assays (hs-cTn) that are analytically more sensitive and more precise at lower concentrations. This change could have a significant impact on EDs and the healthcare system in general. First and foremost, application of the current cutoff definition for NSTEMI to the newer hs-cTn assays will produce an increase in the prevalence of NSTEMI that may or may not be a true increase. This will result in more patients admitted to hospital and given high-risk therapies but with unknown overall changes in morbidity and mortality. Second, recent evidence suggests that the newer assays can help diagnose MI earlier and incremental hs-cTn measurements are potentially prognostic for future cardiovascular events (CVE) including death. Therefore, this inevitable change in assays has the potential to stress current healthcare resources or significantly improve ACS diagnosis and subsequent outcomes. The primary barrier to achieving optimum clinical benefit from the implementation of hs-cTn is the current lack of information. Specifically, the studies on hs-cTn assay cutoffs for early MI diagnosis in North American populations are limited and published research on hs-cTn assays for risk stratification in the ED is non-existent.

The investigators primary objective is to determine which hs-cTn concentration(s) are most predictive of a composite outcome of CVE over time in ED patients presenting with ACS symptoms. In the same population, the investigators also will determine if an early change in cTn and hs-cTn concentrations is more predictive than the peak cTn and hs-cTn concentrations of the composite outcome over time. The investigators intention is that physicians will be able to apply the prognostic cTn and hs-cTn cutoffs from their study results to prescribe the most time-appropriate interventions for their patients. The expected effect of generalized application of the investigators results being positive changes in patient safety, survival, secondary ACS prevention and even ED overcrowding.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
In accordance with the Third Universal Definition of MI and recommendations by both Canadian and international expert groups, we will collect and measure blood for cTnI and hs-cTn measurements at ED presentation and 3 hours later for patients who currently would only undergo a single cTn measurement and 6 hours later if serial cTn measurements are required. This does not preclude cTn measurements for clinical purposes at any additional times of choosing by the EP.
Sampling Method Probability Sample
Study Population Adult residents presenting to any of three EDs in Hamilton, Ontario
Condition Acute Coronary Syndrome (ACS)
Intervention Not Provided
Study Groups/Cohorts Adults (18+) presenting to the ED with symptoms of ACS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2018)
100
Original Estimated Enrollment
 (submitted: November 25, 2013)
1000
Actual Study Completion Date November 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Presenting to any of three EDs in Hamilton, Ontario
  • Chief complaint of suspected symptoms of acute coronary syndrome

Exclusion Criteria:

  • Patients with any component of a composite outcome that includes cardio-vascular death, MI, serious ventricular cardiac dysrhythmia, decompensated congestive heart failure requiring hospital admission and hospital admission for refractory cardiac ischemia that occur prior to the initial blood sample being drawn will be excluded.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01994577
Other Study ID Numbers ROMI-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party McMaster University ( Canadian Institutes of Health Research (CIHR) )
Study Sponsor Canadian Institutes of Health Research (CIHR)
Collaborators Not Provided
Investigators
Principal Investigator: Andrew S Worster, MD, MSc, CCFP(EM), FCFP McMaster University
Principal Investigator: Kavsak Peter, PhD, FCACB, FACB McMaster University
Principal Investigator: Hill Stephen, PhD, FCACB McMaster University
Principal Investigator: McQueen J Mathew, MBChB, PhD, FCACB, FRCPC McMaster University
Principal Investigator: Devereaux P.J., MD, PhD McMaster University
Principal Investigator: Mehta Shamir, MD, MSc McMaster University
Principal Investigator: Ma Jinhui, PhD Children's Hospital of Eastern Ontario Research Insititute
PRS Account McMaster University
Verification Date July 2018