Myocardial InfarctionREMOVE 2NCT06343844
Disparities in Myocardial Infarction Remodeling According to Gender
A study testing cardiac imaging to assess left ventricular volumes and function in people with Myocardial Infarction and Ventricular Remodeling, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Ventricular Remodeling
- What is being tested?
- cardiac imaging to assess left ventricular volumes and function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,650 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2024to 1 Sep 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- First myocardial infarction with ST-segment elevation during the hospital phase
- Coronary angiography performed within 72 hours of the infarction
- Patient affiliated or beneficiary of a social security scheme; Signature of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital, Angers
Angers
LOIC BIERE, PHD, 0241353637 ext. +33
About this study
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.
- Conditions
- Myocardial Infarction, Ventricular Remodeling
- Being tested
- cardiac imaging to assess left ventricular volumes and function
- Keywords
- Non-Interventional Registry, Biorepository Establishment
- Medical subject headings
- Myocardial Infarction, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac imaging to assess left ventricular volumes and functionDiagnostic test
non-invasive cardiac imaging (echocardiography and MRI)
| Study group | Role | What they receive |
|---|---|---|
| case control registry | Other | left ventricular remodeling measurement with cardiac echography Receives: Diagnostic Test: cardiac imaging to assess left ventricular volumes and function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline; 3 months and 1 year after myocardial infarction onset
Secondary outcomes (16)
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)
Measured: 3 months
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)
Measured: 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)
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
Measured: 3 months and 1 year
Explore prognostic disparities between men and women.
Occurrence of complications and cardiovascular events (cardiovascular death, heart failure, stroke, or reinfarction)
Measured: yearly, up to 10 years
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
Measured: yearly, up to 10 years
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
Measured: yearly, up to 10 years
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
Measured: yearly, up to 10 years
Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis
presence or absence of endometriosis
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary
presence or absence of polycystic ovary
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma
presence or absence of uterine fibroma
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy
presence or absence of hormonal therapy
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: date of first period
date of first period
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: pregnancy
number of pregnancy
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: children
number of children
Measured: baseline
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)
Measured: baseline
Assess the risk of remodeling based on specific parameters in female subjects: menopause
absence or presence of menopause
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Jul 2024
- Primary completion1 Nov 2039 (estimated)
- Study completion1 Sep 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343844
- Sponsor's protocol ID
- 49RC23_0070
- Acronym
- REMOVE 2
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparities in Myocardial Infarction Remodeling According to Gender
- ClinicalTrials.gov ID
- NCT06343844
- Acronym / sponsor ID
- REMOVE 2 / 49RC23_0070
- Conditions
- Myocardial Infarction, Ventricular Remodeling
- Keywords
- Non-Interventional Registry, Biorepository Establishment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Nov 2039 (estimated)
- Study completion
- 1 Sep 2040 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case control registry | Other | Diagnostic Test: cardiac imaging to assess left ventricular volumes and functionleft ventricular remodeling measurement with cardiac echography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- First myocardial infarction with ST-segment elevation during the hospital phase
- Coronary angiography performed within 72 hours of the infarction
- Patient affiliated or beneficiary of a social security scheme; Signature of informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac imaging to assess left ventricular volumes and functionnon-invasive cardiac imaging (echocardiography and MRI) | Diagnostic test | case control registry |
Primary outcome
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)
16 secondary outcomes
Evaluate the evolution of remodeling at Month 3
Time frame: 3 months
Assess remodeling changes between inclusion and Month 12
Time frame: 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
Explore prognostic disparities between men and women.
Time frame: yearly, up to 10 years
Evaluate lifestyle habits up to 10 years: outcome anxiety/depression
Time frame: yearly, up to 10 years
Evaluate lifestyle habits up to 10 years: outcome diet score
Time frame: yearly, up to 10 years
Evaluate lifestyle habits up to 10 years: outcome physical activity
Time frame: yearly, up to 10 years
Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: date of first period
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: pregnancy
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: children
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event
Time frame: baseline
Assess the risk of remodeling based on specific parameters in female subjects: menopause
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac imaging to assess left ventricular volumes and function in people with Myocardial Infarction and Ventricular Remodeling, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LOIC BIERE, PHD (02 41 35 36 37 ext. +33, LoBiere@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asses left ventricular remodeling disparities between genders (time frame: baseline; 3 months and 1 year after myocardial infarction onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.