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Diagnostic Test
Lowering the hs-cTn Threshold for Heart Attack in Women (CODE-MI Trial)
N/A
Waitlist Available
Led By Karin Humphries, DSc
Research Sponsored by BC Centre for Improved Cardiovascular Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post index emergency department presentation
Awards & highlights
CODE-MI Trial Summary
This trial is testing whether a different, lower threshold for diagnosing a heart attack in women will lead to better outcomes.
Eligible Conditions
- Heart Attack
- Gender Differences
- High Sensitivity Troponin Test
CODE-MI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year post index emergency department presentation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year post index emergency department presentation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with all-cause mortality, non-fatal myocardial infarction, hospitalization for incident heart failure, or urgent/emergent coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery)
Secondary outcome measures
Number of patients with a) Non-fatal myocardial infarction or all-cause mortality; b) Urgent/emergent coronary revascularization or all-cause mortality; c) Hospitalization for heart failure or all-cause mortality.
Proportion of patients who fill at least one prescription for evidence-based cardiac medications
Diagnostic tests
CODE-MI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The intervention is the introduction of a lower female threshold. In cluster-randomized trials, the cluster (i.e., hospital) is the unit of randomization.
Group II: ControlActive Control1 Intervention
The control phase will be standard of care, with the use of an overall population hs-cTn T and I threshold, for both men and women, to identify those with myocardial injury/infarction.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,343 Previous Clinical Trials
26,429,093 Total Patients Enrolled
BC Centre for Improved Cardiovascular HealthLead Sponsor
3 Previous Clinical Trials
926 Total Patients Enrolled
Karin Humphries, DScPrincipal InvestigatorMedicine, Cardiology, UBC, BC Centre for Improved Cardiovascular Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a specific type of heart attack called ST elevation myocardial infarction (STEMI).You are 20 years old or older.You are currently experiencing chest pain or having trouble breathing that may be related to a heart problem.You must have had one high-sensitivity cardiac troponin test.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you have any open enrollment spots for this trial?
"Affirmative. Clinicaltrials.gov contains information corroborating that this clinical trial, which was published on February 8th 2020, is actively enrolling patients. Approximately 24000 individuals need to be recruited from a single site."
Answered by AI
How many participants are currently included in this research?
"Affirmative. Information hosted on clinicaltrials.gov verifies that this investigation, which was initially made available on February 8th 2020, is presently recruiting participants. Approximately 24000 individuals must be enlisted from a single location."
Answered by AI
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