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

Myocardial Infarction Clinical Trial

— CODE-MI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819894
• Other study ID #: H18-02116
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2020
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: BC Centre for Improved Cardiovascular Health
• Contact: Mona Izadnegahdar, PhD
• Phone: 604-6822344
• Email: mizadnegahdar[@]icvhealth.ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In subjects with suspected acute coronary syndromes (ACS), females are significantly less likely to undergo investigations, receive evidence-based treatments, and consistently have worse outcomes than males. The gap in outcomes is particularly marked among adults < 55 years of age. Sex differences in symptom presentation and in the diagnostic threshold for cardiac biomarkers have been suggested as reasons for the under-diagnosis and under-treatment of women. Cardiac troponin (cTn) T and I are proteins specific to the myocardium, which with elevated and changing concentrations detected in the blood, along with signs or symptoms consistent with myocardial ischemia, are indicative of a diagnosis of myocardial infarction (MI). With the introduction of high-sensitivity (hs) cTn tests, which allow the detection of very low concentrations of troponin, it has become evident that the level of cTn in a healthy population is approximately two-fold higher in males than in females.

Consequently, the 99th percentile threshold for cTn, the reference value used in diagnosis of MI, is lower in females compared to males. Despite this evidence and recent guidelines recommending the use of sex specific thresholds, a single, overall cTn threshold is still being used for diagnosis of MI, in both men and women, in most clinical settings.

There is mounting evidence from several jurisdictions that the rate of MI is increasing among younger females, and that there is a persistent under-diagnosis, under-treatment, and high risk of adverse outcomes among females, especially younger females, compared to their male counterparts. A better approach to the diagnostic assessment of females presenting to the emergency department (ED) with chest pain is therefore urgently needed. Additionally, several Canadian hospitals have recently made the transition from sensitive to high sensitivity cTn assays, allowing for the examination of subtle but important sex-specific differences in cTn concentrations. With this background, the investigators propose a nationwide, randomized clinical trial (RCT) to determine whether establishing female thresholds results in improved diagnosis and treatment of MI and therefore improved prognosis in women.

To determine whether the use of female hs-cTn thresholds in the assessment of women presenting to the ED with chest pain suggestive of cardiac ischemia, improves diagnostic assessment, treatment and 1-year outcomes. Specifically, the investigators will examine the impact of using female hs-cTn thresholds on:

• Diagnostic and therapeutic strategies;

• Prognosis: 1-year all-cause mortality, non-fatal MI, incident heart failure (HF) hospitalization or emergent/urgent coronary revascularization;

• Costs of diagnostic testing and treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24000
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• >20 years of age

• Present to the ED with chest pain or shortness of breath suggestive of ischemia

• Have a valid personal health identifier

• Have 1 hs-cTn test result

Exclusion Criteria:

• Have ST elevation myocardial infarction (STEMI)

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

Related Conditions & MeSH terms

• High Sensitivity Troponin
• Hypersensitivity
• Infarction
• Myocardial Infarction
• Sex Differences

Intervention

Diagnostic Test:
• Introduction of a lower female hs-cTn threshold
The new female hs-cTn threshold will be baed on current recommendations for each of the assays used (hs-cTn T and I). The hospitals are the unit of randomization. At 5-month intervals, randomly selected hospitals will be advised that they are to transition to the intervention phase. For all men, the standard of care, overall population threshold will be used throughout the entire study.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
BC Centre for Improved Cardiovascular Health	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		1-year post index emergency department presentation
Secondary	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.		1-year post index emergency department presentation
Secondary	Proportion of patients who fill at least one prescription for evidence-based cardiac medications	Medications include beta-blockers, Angiotensin Converting Enzyme (ACE)-I/Angiotensin II receptor blockers (ARB), statins, anti-platelets	Within 90 days of ED visit
Secondary	Proportion of patients who undergo diagnostic tests	Diagnostic tests include nuclear medicine cardiac scan, exercise stress test, diagnostic cardiac catheterization/CT angiogram or echocardiogram	Within 90 days of ED visit