Clinical trial NCT06343844: Disparities in Myocardial Infarction Remodeling According to Gender
Official title: Disparities in Myocardial Infarction Remodeling According to Gender
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Ventricular Remodeling
Keywords: Non-Interventional Registry
Biorepository Establishment
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-04-03
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Asses left ventricular remodeling disparities between genders
timeFrame: baseline; 3 months and 1 year after myocardial infarction onset
Secondary outcomes:
measure: Evaluate the evolution of remodeling at Month 3
timeFrame: 3 months
measure: Assess remodeling changes between inclusion and Month 12
timeFrame: 1 year
measure: 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)
timeFrame: 3 months and 1 year
measure: Explore prognostic disparities between men and women.
timeFrame: yearly, up to 10 years
measure: Evaluate lifestyle habits up to 10 years: outcome anxiety/depression
timeFrame: yearly, up to 10 years
measure: Evaluate lifestyle habits up to 10 years: outcome diet score
timeFrame: yearly, up to 10 years
measure: Evaluate lifestyle habits up to 10 years: outcome physical activity
timeFrame: yearly, up to 10 years
measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: date of first period
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: pregnancy
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: children
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event
timeFrame: baseline
measure: Assess the risk of remodeling based on specific parameters in female subjects: menopause
timeFrame: baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital, Angers
Study officials:
References: