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

NCT03819894 | Active Not Recruiting DMC

• 1 other identifier: H18-02116
• Study Type: interventional
• Target: 24,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction; Sex Differences; High Sensitivity Troponin

Keywords

myocardial infarction; sex differences; high-sensitivity cardiac troponin; biomarkers; heart attack; emergency department; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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)

  Composite of all-cause mortality, re-admission for non-fatal MI, incident HF, or urgent/emergent coronary revascularization

  2-year post index emergency department presentation

Secondary Outcomes (3)

• 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.

  2-year post index emergency department presentation

• Proportion of patients who fill at least one prescription for evidence-based cardiac medications

  Within 90 days of ED visit

• Proportion of patients who undergo diagnostic tests

  Within 90 days of ED visit

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention is the introduction of a lower female threshold. In cluster-randomized trials, the cluster (i.e., hospital) is the unit of randomization.

Diagnostic Test: Introduction of a lower female hs-cTn threshold

Control

NO 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.

Interventions

Introduction of a lower female hs-cTn threshold DIAGNOSTIC_TEST

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.

Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• BC Centre for Improved Cardiovascular Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Zhao Y, Izadnegahdar M, Lee MK, Kavsak PA, Singer J, Scheuermeyer F, Udell JA, Robinson S, Norris CM, Lyon AW, Pilote L, Cox J, Hassan A, Rychtera A, Johnson D, Mills NL, Christenson J, Humphries KH. High-Sensitivity Cardiac Troponin-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): Rationale and design for a multicenter, stepped-wedge, cluster-randomized trial. Am Heart J. 2020 Nov;229:18-28. doi: 10.1016/j.ahj.2020.06.013. Epub 2020 Jun 25.

  PMID: 32916606 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Emergencies; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Disease Attributes

Study Officials

• Karin Humphries, DSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster-randomized trial. Unidirectional crossover design where clusters cross over sequentially, in random order, from the control to intervention phase.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 29, 2019
• Study Start: February 8, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CA (1)