Myocardial Infarction Clinical Trial
— REMOVE 2Official title:
Disparities in Myocardial Infarction Remodeling According to Gender
Verified date | March 2024 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 1650 |
Est. completion date | July 1, 2040 |
Est. primary completion date | September 1, 2039 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | 3 months | |
Secondary | 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) | 1 year | |
Secondary | 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 | 3 months and 1 year | |
Secondary | Explore prognostic disparities between men and women. | Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction) | yearly, up to 10 years | |
Secondary | Evaluate lifestyle habits up to 10 years: outcome anxiety/depression | Anxiety/Depression (A.D) score: 2 scales from 0 to 21, the greatest the more prone to either anxiety or depression | yearly, up to 10 years | |
Secondary | Evaluate lifestyle habits up to 10 years: outcome diet score | Mediteranean diet score (MED): from 0 to 14, the greatest the more relevant for mediteranean diet | yearly, up to 10 years | |
Secondary | Evaluate lifestyle habits up to 10 years: outcome physical activity | physical activity: lipid research clinics (LRC); 2 scales from 1 to 5, the greatest the less active | yearly, up to 10 years | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis | presence or absence of endometriosis | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary | presence or absence of polycystic ovary | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma | presence or absence of uterine fibroma | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy | presence or absence of hormonal therapy | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: date of first period | date of first period | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: pregnancy | number of pregnancy | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: children | number of children | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event | absence or presence of obstetrical events (hypertension, diabete, microsomia and macrosomia) | baseline | |
Secondary | Assess the risk of remodeling based on specific parameters in female subjects: menopause | absence or presence of menopause | baseline |
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