Myocardial Infarction, Ventricular Remodeling
Conditions
Keywords
Non-Interventional Registry, Biorepository Establishment
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.
Interventions
DIAGNOSTIC_TESTcardiac imaging to assess left ventricular volumes and function
non-invasive cardiac imaging (echocardiography and MRI)
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asses left ventricular remodeling disparities between genders | baseline; 3 months and 1 year after myocardial infarction onset | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the evolution of remodeling at Month 3 | 3 months | Changes in ventricular volumes between acute phase and 3 months measured with cardiac imaging (echocardiography and MRI) |
| Assess remodeling changes between inclusion and Month 12 | 1 year | Changes in ventricular volumes between acute phase and 1 year measured with cardiac imaging (echocardiography and MRI) |
| 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 | 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 |
| Explore prognostic disparities between men and women. | yearly, up to 10 years | Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction) |
| Evaluate lifestyle habits up to 10 years: outcome anxiety/depression | yearly, up to 10 years | Anxiety/Depression (A.D) score: 2 scales from 0 to 21, the greatest the more prone to either anxiety or depression |
| Evaluate lifestyle habits up to 10 years: outcome diet score | yearly, up to 10 years | Mediteranean diet score (MED): from 0 to 14, the greatest the more relevant for mediteranean diet |
| Evaluate lifestyle habits up to 10 years: outcome physical activity | yearly, up to 10 years | physical activity: lipid research clinics (LRC); 2 scales from 1 to 5, the greatest the less active |
| Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis | baseline | presence or absence of endometriosis |
| Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary | baseline | presence or absence of polycystic ovary |
| Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma | baseline | presence or absence of uterine fibroma |
| Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy | baseline | presence or absence of hormonal therapy |
| Assess the risk of remodeling based on specific parameters in female subjects: date of first period | baseline | date of first period |
| Assess the risk of remodeling based on specific parameters in female subjects: pregnancy | baseline | number of pregnancy |
| Assess the risk of remodeling based on specific parameters in female subjects: children | baseline | number of children |
| Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event | baseline | absence or presence of obstetrical events (hypertension, diabete, microsomia and macrosomia) |
| Assess the risk of remodeling based on specific parameters in female subjects: menopause | baseline | absence or presence of menopause |
Countries
France
Contacts
CONTACTLOIC BIERE, PHD
CONTACTVIVIANE CASSISA
Outcome results
None listed