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Recruiting NCT06343844

Disparities in Myocardial Infarction Remodeling According to Gender

No phase Interventional Myocardial Infarction Ventricular Remodeling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cardiac imaging to assess left ventricular volumes and function.
Who it may be relevant to
Registry conditions: Myocardial Infarction, Ventricular Remodeling. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test cardiac imaging to assess left ventricular volumes and function
    non-invasive cardiac imaging (echocardiography and MRI)

Primary outcome measures

  • Asses left ventricular remodeling disparities between genders [Time frame: baseline; 3 months and 1 year after myocardial infarction onset]
Secondary outcome measures (12)
  • Evaluate the evolution of remodeling at Month 3 [Time frame: 3 months]
  • Assess remodeling changes between inclusion and Month 12 [Time frame: 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) [Time frame: 3 months and 1 year]
  • Explore prognostic disparities between men and women. [Time frame: yearly, up to 10 years]
  • Evaluate lifestyle habits up to 10 years: outcome anxiety/depression [Time frame: yearly, up to 10 years]
  • Evaluate lifestyle habits up to 10 years: outcome diet score [Time frame: yearly, up to 10 years]
  • Evaluate lifestyle habits up to 10 years: outcome physical activity [Time frame: yearly, up to 10 years]
  • Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis [Time frame: baseline]
  • Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary [Time frame: baseline]
  • Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma [Time frame: baseline]
  • Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy [Time frame: baseline]
  • Assess the risk of remodeling based on specific parameters in female subjects: date of first period [Time frame: baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • University Hospital, Angers — Angers

Identifiers

NCT: NCT06343844 · 49RC23_0070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗