Disparities in Myocardial Infarction Remodeling According to Gender
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
cardiac imaging to assess left ventricular volumes and function
Diagnostic testnon-invasive cardiac imaging (echocardiography and MRI)
Treatment groups
1,650 Participants
are divided into 1 treatment groupGroup A: case control registryOther 1 intervention
Trial outcomes
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)
Time frame
baseline; 3 months and 1 year after myocardial infarction onsetSecondary outcomes
1
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)
Time frame
3 months2
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)
Time frame
1 year3
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
Time frame
3 months and 1 year4
Explore prognostic disparities between men and women.
Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction)
Time frame
yearly, up to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov