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NCT Number: NCT06343844

Disparities in Myocardial Infarction Remodeling According to Gender

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Angers

Angers, France

Location status: Recruiting

Location contact

LOIC BIERE, PHD

CONTACT

0241353637 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac imaging to assess left ventricular volumes and function

Diagnostic Test

non-invasive cardiac imaging (echocardiography and MRI)

Primary outcomes

  1. Asses left ventricular remodeling disparities between genders

    Time frame: 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 outcomes

  1. Evaluate the evolution of remodeling at Month 3

    Time frame: 3 months

    Changes in ventricular volumes between acute phase and 3 months measured with cardiac imaging (echocardiography and MRI)

  2. Assess remodeling changes between inclusion and Month 12

    Time frame: 1 year

    Changes in ventricular volumes between acute phase and 1 year measured with cardiac imaging (echocardiography and MRI)

  3. 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)

    Time frame: 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

  4. Explore prognostic disparities between men and women.

    Time frame: yearly, up to 10 years

    Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction)

  5. Evaluate lifestyle habits up to 10 years: outcome anxiety/depression

    Time frame: 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

  6. Evaluate lifestyle habits up to 10 years: outcome diet score

    Time frame: yearly, up to 10 years

    Mediteranean diet score (MED): from 0 to 14, the greatest the more relevant for mediteranean diet

  7. Evaluate lifestyle habits up to 10 years: outcome physical activity

    Time frame: yearly, up to 10 years

    physical activity: lipid research clinics (LRC); 2 scales from 1 to 5, the greatest the less active

  8. Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis

    Time frame: baseline

    presence or absence of endometriosis

  9. Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary

    Time frame: baseline

    presence or absence of polycystic ovary

  10. Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma

    Time frame: baseline

    presence or absence of uterine fibroma

  11. Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy

    Time frame: baseline

    presence or absence of hormonal therapy

  12. Assess the risk of remodeling based on specific parameters in female subjects: date of first period

    Time frame: baseline

    date of first period

  13. Assess the risk of remodeling based on specific parameters in female subjects: pregnancy

    Time frame: baseline

    number of pregnancy

  14. Assess the risk of remodeling based on specific parameters in female subjects: children

    Time frame: baseline

    number of children

  15. Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event

    Time frame: baseline

    absence or presence of obstetrical events (hypertension, diabete, microsomia and macrosomia)

  16. Assess the risk of remodeling based on specific parameters in female subjects: menopause

    Time frame: baseline

    absence or presence of menopause

Study contacts

Contact information is provided by the study sponsor or research team.

LOIC BIERE, PHD

CONTACT

[email protected]

02 41 35 36 37 ext. +33

VIVIANE CASSISA

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: REMOVE 2

Important dates

Study start
2024
Primary completion
2039
Study completion
2040
First posted
Apr 3, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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