Disparities in Myocardial Infarction Remodeling According to Gender (REMOVE 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Ventricular Remodeling
• Intervention / Treatment: Diagnostic test: cardiac imaging to assess left ventricular volumes and function

• Study Type: Interventional
• Enrollment (Estimated): 1650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LOIC BIERE, PHD; Phone Number: +33 02 41 35 36 37; Email: LoBiere@chu-angers.fr
• Study Contact Backup: Name: VIVIANE CASSISA; Phone Number: +33 02 41 35 36 37; Email: DRCI-Promotion-Interne@chu-angers.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • University Hospital, Angers
    • Contact: LOIC BIERE, PHD; Phone Number: +33 0241353637

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: case control registry; left ventricular remodeling measurement with cardiac echography	Diagnostic test: cardiac imaging to assess left ventricular volumes and function; non-invasive cardiac imaging (echocardiography and MRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asses left ventricular remodeling disparities between genders	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)	baseline; 3 months and 1 year after myocardial infarction onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the evolution of remodeling at Month 3	Changes in ventricular volumes between acute phase and 3 months measured with cardiac imaging (echocardiography and MRI)	3 months
Assess remodeling changes between inclusion and Month 12	Changes in ventricular volumes between acute phase and 1 year measured with cardiac imaging (echocardiography and MRI)	1 year
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)	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	3 months and 1 year
Explore prognostic disparities between men and women.	Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction)	yearly, up to 10 years
Evaluate lifestyle habits up to 10 years: outcome anxiety/depression	Anxiety/Depression (A.D) score: 2 scales from 0 to 21, the greatest the more prone to either anxiety or depression	yearly, up to 10 years
Evaluate lifestyle habits up to 10 years: outcome diet score	Mediteranean diet score (MED): from 0 to 14, the greatest the more relevant for mediteranean diet	yearly, up to 10 years
Evaluate lifestyle habits up to 10 years: outcome physical activity	physical activity: lipid research clinics (LRC); 2 scales from 1 to 5, the greatest the less active	yearly, up to 10 years
Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis	presence or absence of endometriosis	baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary	presence or absence of polycystic ovary	baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma	presence or absence of uterine fibroma	baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy	presence or absence of hormonal therapy	baseline
Assess the risk of remodeling based on specific parameters in female subjects: date of first period	date of first period	baseline
Assess the risk of remodeling based on specific parameters in female subjects: pregnancy	number of pregnancy	baseline
Assess the risk of remodeling based on specific parameters in female subjects: children	number of children	baseline
Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event	absence or presence of obstetrical events (hypertension, diabete, microsomia and macrosomia)	baseline
Assess the risk of remodeling based on specific parameters in female subjects: menopause	absence or presence of menopause	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): November 1, 2039
• Study Completion (Estimated): September 1, 2040

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Non-Interventional Registry; Biorepository Establishment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Ventricular Remodeling
• Other Study ID Numbers: 49RC23_0070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No