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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) )

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.

Condition or disease
Acute Coronary Syndrome (ACS)

  Show Detailed Description

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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
Adults (18+) presenting to the ED with symptoms of ACS



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult residents presenting to any of three EDs in Hamilton, Ontario
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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Canadian Institutes of Health Research (CIHR)
ClinicalTrials.gov Identifier: NCT01994577     History of Changes
Other Study ID Numbers: ROMI-3
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Keywords provided by McMaster University ( Canadian Institutes of Health Research (CIHR) ):
Emergency Department
Cardiac troponin
Myocardial infarction

Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases