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 2-year post index emergency department presentation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a different, lower threshold for diagnosing a heart attack in women will lead to better outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic criteria rather than medication, there are no direct side effects from interventions. However, changes in diagnosis could affect subsequent treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-year post index emergency department presentation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-year post index emergency department presentation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-year post index emergency department presentation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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