Disparities in Myocardial Infarction Remodeling According to Gender

University Hospital, Angers1 site in 1 country1,650 target enrollmentJuly 15, 2024

ConditionsMyocardial Infarction Ventricular Remodeling

Interventionscardiac imaging to assess left ventricular volumes and function

Overview

Phase: Not Applicable
Intervention: cardiac imaging to assess left ventricular volumes and function
Conditions: Myocardial Infarction
Sponsor: University Hospital, Angers
Enrollment: 1650
Locations: 1
Primary Endpoint: Asses left ventricular remodeling disparities between genders
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study.

Registry

clinicaltrials.gov

Start Date

July 15, 2024

End Date

September 1, 2040

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Angers

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years
•First myocardial infarction with ST-segment elevation during the hospital phase
•Coronary angiography performed within 72 hours of the infarction
•Inclusion in the RIMA registry
•Patient affiliated or beneficiary of a social security scheme; Signature of informed consent

Exclusion Criteria

•Patients already enrolled in the study
•Poor understanding of the French language
•Pregnant, breastfeeding, or postpartum women
•Individuals deprived of liberty by judicial or administrative decision; Individuals receiving psychiatric care under coercion
•Individuals subject to a legal protection measure; Individuals incapable of giving consent

Arms & Interventions

case control registry

left ventricular remodeling measurement with cardiac echography

Intervention: cardiac imaging to assess left ventricular volumes and function

Outcomes

Primary Outcomes

Asses left ventricular remodeling disparities between genders

Time Frame: baseline; 3 months and 1 year after myocardial infarction onset

The primary outcome measure will be the occurrence of left ventricular remodeling (defined as a change in ventricular volume of more than 10% during follow-up) measured with cardiac imaging (echocardiography and MRI)

Secondary Outcomes

Evaluate the evolution of remodeling at Month 3(3 months)
Assess remodeling changes between inclusion and Month 12(1 year)
Explore prognostic disparities between men and women.(yearly, up to 10 years)
Evaluate lifestyle habits up to 10 years: outcome physical activity(yearly, up to 10 years)
Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy(baseline)
Assess the prevalence of comorbidities and their impact on the effect on the outcome: post-infarction cardiac remodeling with gender (cardiovascular risk factors, renal function, hepatic functionperipheral artery disease, way of life)(3 months and 1 year)
Evaluate lifestyle habits up to 10 years: outcome diet score(yearly, up to 10 years)
Evaluate lifestyle habits up to 10 years: outcome anxiety/depression(yearly, up to 10 years)
Assess the risk of remodeling based on specific parameters in female subjects: date of first period(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: pregnancy(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: children(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event(baseline)
Assess the risk of remodeling based on specific parameters in female subjects: menopause(baseline)