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
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Condition or disease |
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Acute Coronary Syndrome (ACS) |

Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Determining the Optimum Treatment Cutoffs for Cardiac Troponin Assays in Patients Presenting to the Emergency Department With Suspected Cardiac Ischemia |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | August 2017 |
Actual Study Completion Date : | November 2017 |

Group/Cohort |
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Adults (18+) presenting to the ED with symptoms of ACS |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994577
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada, L8L 2X2 |
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 |
Responsible Party: | Canadian Institutes of Health Research (CIHR) |
ClinicalTrials.gov Identifier: | NCT01994577 |
Other Study ID Numbers: |
ROMI-3 |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | July 26, 2018 |
Last Verified: | July 2018 |
Emergency Department Cardiac troponin Myocardial infarction |
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |