Disparities in Myocardial Infarction Remodeling According to Gender

Not Applicable

Recruiting

• Conditions: Myocardial Infarction; Ventricular Remodeling
• Interventions: Diagnostic Test: cardiac imaging to assess left ventricular volumes and function

• Registration Number: NCT06343844
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-03
• Status Verified: 2024-07
• Study Start: 2024-07-15
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2039-11-01
• Study Completion: 2040-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
case control registry	cardiac imaging to assess left ventricular volumes and function	left ventricular remodeling measurement with cardiac echography

Primary Outcome Measures

Name	Time	Method
Asses left ventricular remodeling disparities between genders	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 Outcome Measures

Name	Time	Method
Evaluate the evolution of remodeling at Month 3	3 months	Changes in ventricular volumes between acute phase and 3 months measured with cardiac imaging (echocardiography and MRI)
Assess remodeling changes between inclusion and Month 12	1 year	Changes in ventricular volumes between acute phase and 1 year measured with cardiac imaging (echocardiography and MRI)
Explore prognostic disparities between men and women.	yearly, up to 10 years	Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction)
Evaluate lifestyle habits up to 10 years: outcome physical activity	yearly, up to 10 years	physical activity: lipid research clinics (LRC); 2 scales from 1 to 5, the greatest the less active
Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis	baseline	presence or absence of endometriosis
Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary	baseline	presence or absence of polycystic ovary
Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma	baseline	presence or absence of uterine fibroma
Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy	baseline	presence or absence of hormonal therapy
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	renal function: uremia and creatinine levels, combined with an assessment of the protein-to-creatinine ratio in urine samples, and a cyto-bacteriological examination of urine to detect hematuria; hepatic function: The Fibroscan® is a device that enables a non-invasive and efficient assessment of liver fibrosis and steatosis within minutes at the patient's bedside, providing an immediate result displayed on the device screen; peripheral artery disease: Doppler echocardiography of the supra-aortic trunks; way of life : dietetary, stress and physical activity scores common CV risk factors: prior history of hypertension, hypercholesterolaemia, tobacco use, diabetes
Evaluate lifestyle habits up to 10 years: outcome diet score	yearly, up to 10 years	Mediteranean diet score (MED): from 0 to 14, the greatest the more relevant for mediteranean diet
Evaluate lifestyle habits up to 10 years: outcome anxiety/depression	yearly, up to 10 years	Anxiety/Depression (A.D) score: 2 scales from 0 to 21, the greatest the more prone to either anxiety or depression
Assess the risk of remodeling based on specific parameters in female subjects: date of first period	baseline	date of first period
Assess the risk of remodeling based on specific parameters in female subjects: pregnancy	baseline	number of pregnancy
Assess the risk of remodeling based on specific parameters in female subjects: children	baseline	number of children
Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event	baseline	absence or presence of obstetrical events (hypertension, diabete, microsomia and macrosomia)
Assess the risk of remodeling based on specific parameters in female subjects: menopause	baseline	absence or presence of menopause

Trial Locations

Locations (1)

University Hospital, Angers; 🇫🇷 Angers, France