Disparities in Myocardial Infarction Remodeling According to Gender

Myocardial Infarction Clinical Trial

— REMOVE 2  

Official title:

Disparities in Myocardial Infarction Remodeling According to Gender

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343844
• Other study ID #: 49RC23_0070
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2040

Study information

• Verified date: March 2024
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Ventricular Remodeling

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

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