Disparities in Myocardial Infarction Remodeling According to Gender (REMOVE 2)

February 6, 2026 updated by: University Hospital, Angers
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • University Hospital, Angers
        • Contact:
          • LOIC BIERE, PHD
          • Phone Number: +33 0241353637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: case control registry
left ventricular remodeling measurement with cardiac echography
Diagnostic test: cardiac imaging to assess left ventricular volumes and function
non-invasive cardiac imaging (echocardiography and MRI)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
baseline; 3 months and 1 year after myocardial infarction onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
3 months
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)
1 year
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
3 months and 1 year
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)
yearly, up to 10 years
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
yearly, up to 10 years
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
yearly, up to 10 years
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
yearly, up to 10 years
Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis
Time Frame: baseline
presence or absence of endometriosis
baseline
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
baseline
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
baseline
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
baseline
Assess the risk of remodeling based on specific parameters in female subjects: date of first period
Time Frame: baseline
date of first period
baseline
Assess the risk of remodeling based on specific parameters in female subjects: pregnancy
Time Frame: baseline
number of pregnancy
baseline
Assess the risk of remodeling based on specific parameters in female subjects: children
Time Frame: baseline
number of children
baseline
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)
baseline
Assess the risk of remodeling based on specific parameters in female subjects: menopause
Time Frame: baseline
absence or presence of menopause
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2039

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 49RC23_0070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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