Lowering the hs-cTn Threshold for Heart Attack in Women

(CODE-MI Trial)

Overseen By Salima Jutha, CCRA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BC Centre for Improved Cardiovascular Health

Disqualifiers: STEMI, Non-resident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The project is focussed on evaluating the impact of using a female-specific threshold in the diagnosis of myocardial infarction. This female threshold is lower than the overall hs-cTn threshold currently in use. The investigators hypothesize that this change in process, applied at the hospital level, will lead to better assessment, treatment and outcomes of women presenting to the emergency department with chest pain that is cardiac in nature.

Who Is on the Research Team?

Karin Humphries, DSc

Principal Investigator

Medicine, Cardiology, UBC, BC Centre for Improved Cardiovascular Health

Are You a Good Fit for This Trial?

This trial is for women over 20 who visit the emergency department with chest pain or shortness of breath that may indicate a heart issue. They must have had a high-sensitivity troponin test and live in the same province as the hospital. Women with ST elevation myocardial infarction are excluded.

Inclusion Criteria

Have a valid personal health identifier

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.

Exclusion Criteria

Not residents in the same province as the hospital ED to which they present or move out of province within a year

You have a specific type of heart attack called ST elevation myocardial infarction (STEMI).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Standard of care using overall population hs-cTn T and I threshold for both men and women

Duration not specified

Intervention Phase

Introduction of a lower female threshold for hs-cTn in the diagnosis of myocardial infarction

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 2-year outcomes such as all-cause mortality and non-fatal myocardial infarction

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Introduction of a lower female hs-cTn threshold

Trial Overview The study tests whether using a lower threshold for troponin levels (a marker in blood) specifically for women improves diagnosis and treatment of heart attacks when they arrive at the hospital.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

BC Centre for Improved Cardiovascular Health

Lead Sponsor

Trials

4

Recruited

24,900+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+