Optimum Troponin Cutoffs for ACS in the ED (ROMI-3)
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ClinicalTrials.gov Identifier: NCT01994577
Recruitment Status :
First Posted : November 26, 2013
Last Update Posted : July 26, 2018
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University ( Canadian Institutes of Health Research (CIHR) )
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.
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.
Biospecimen Retention: Samples Without DNA
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult residents presenting to any of three EDs in Hamilton, Ontario
18 years of age or older
Presenting to any of three EDs in Hamilton, Ontario
Chief complaint of suspected symptoms of acute coronary syndrome
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.