NCT03819894: CODE-MI

Hs-cTn - Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women

Active, enrolled NA Last updated 9 October 2024

What this trial tests

NA trial testing Introduction of a lower female hs-cTn threshold in Myocardial Infarction in 24,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 February 2020

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	BC Centre for Improved Cardiovascular Health
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	health services research
Enrollment	24,000
Start date	8 February 2020
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across Canada

Drugs / interventions tested

• Introduction of a lower female hs-cTn threshold

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Sex Differences — all drugs for Sex Differences →
• High Sensitivity Troponin — all drugs for High Sensitivity Troponin →

Sponsor

BC Centre for Improved Cardiovascular Health

Who can join

20 and older, any sex, with Myocardial Infarction or Sex Differences. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sex-Specific Thresholds of High-Sensitivity Troponin in Patients With Suspected Acute Coronary Syndrome.
   Lee KK, Ferry AV, Anand A, Strachan FE, et al · · 2019 · cited 93× · PMID 31623760 · DOI 10.1016/j.jacc.2019.07.082
2. Sex-Related Outcomes of Medical, Percutaneous, and Surgical Interventions for Coronary Artery Disease: JACC Focus Seminar 3/7.
   Gaudino M, Di Franco A, Cao D, Giustino G, et al · · 2022 · cited 51× · PMID 35393023 · DOI 10.1016/j.jacc.2021.07.066
3. The Canadian Women's Heart Health Alliance ATLAS on the Epidemiology, Diagnosis, and Management of Cardiovascular Disease in Women - Chapter 9: Summary of Current Status, Challenges, Opportunities, and Recommendations.
   Mulvagh SL, Colella TJF, Gulati M, Crosier R, et al · · 2024 · cited 4× · PMID 38487064 · DOI 10.1016/j.cjco.2023.12.001
4. The Development of a Chest-Pain Protocol for Women Presenting to the Emergency Department.
   Jaffer S, Noble M, Pozgay A, Randhawa V, et al · · 2024 · cited 2× · PMID 38487055 · DOI 10.1016/j.cjco.2023.12.003
5. The Clinical Validation of a Common Analytical Change Criteria for Cardiac Troponin for Ruling in an Acute Cardiovascular Outcome in Patients Presenting with Ischemic Chest Pain Symptoms.
   Kavsak PA, Sharif S, Globe I, Ainsworth C, et al · · 2023 · cited 1× · PMID 37623348 · DOI 10.3390/jcdd10080335