Disparities in Myocardial Infarction Remodeling According to Gender

NCT06343844 | Recruiting

• 1 other identifier: 49RC23_0070
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Ventricular Remodeling

Keywords

Non-Interventional Registry; Biorepository Establishment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Evaluate the evolution of remodeling at Month 3

  3 months

• Assess remodeling changes between inclusion and Month 12

  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)

  3 months and 1 year

• Explore prognostic disparities between men and women.

  yearly, up to 10 years

• Evaluate lifestyle habits up to 10 years: outcome anxiety/depression

  yearly, up to 10 years

Study Arms (1)

case control registry

OTHER

left ventricular remodeling measurement with cardiac echography

Diagnostic Test: cardiac imaging to assess left ventricular volumes and function

Interventions

cardiac imaging to assess left ventricular volumes and function DIAGNOSTIC_TEST

non-invasive cardiac imaging (echocardiography and MRI)

case control registry

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital, Angers

Angers, France

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Ventricular Remodeling

Condition Hierarchy (Ancestors)

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

Central Study Contacts

LOIC BIERE, PHD

CONTACT

02 41 35 36 37; LoBiere@chu-angers.fr

VIVIANE CASSISA

CONTACT

02 41 35 36 37; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: April 3, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): November 1, 2039
• Study Completion (Estimated): September 1, 2040
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

FR (1)