Acute Coronary Syndrome (ACS) Clinical Trial
— ROMI-3Official title:
Determining the Optimum Treatment Cutoffs for Cardiac Troponin Assays in Patients Presenting to the Emergency Department With Suspected Cardiac Ischemia
NCT number | NCT01994577 |
Other study ID # | ROMI-3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | November 2017 |
Verified date | July 2018 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Outcome | 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. | 7, 30, and 180 days |
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