ClinicalTrials.gg
RecruitingNCT06343844REMOVE 2Updated Feb 9, 2026

Disparities in Myocardial Infarction Remodeling According to Gender

An interventional study of cardiac imaging to assess left ventricular volumes and function in Myocardial Infarction and Ventricular Remodeling, sponsored by University Hospital, Angers. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,650
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction
  • Ventricular Remodeling

Keywords

  • Non-Interventional Registry
  • Biorepository Establishment
03

In context

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

This study's planned enrollment of 1,650 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,650 participants (estimated)

Study arms

  • Other
    case control registry

    left ventricular remodeling measurement with cardiac echography

    Diagnostic Test: cardiac imaging to assess left ventricular volumes and function

Interventions

  • Diagnostic testcardiac imaging to assess left ventricular volumes and function

    non-invasive cardiac imaging (echocardiography and MRI)

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: baseline; 3 months and 1 year after myocardial infarction onset

Secondary outcomes

  1. 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)

    Time frame: 3 months

  2. 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)

    Time frame: 1 year

  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)

    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

    Time frame: 3 months and 1 year

  4. Explore prognostic disparities between men and women.

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

    Time frame: yearly, up to 10 years

  5. 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

    Time frame: yearly, up to 10 years

  6. 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

    Time frame: yearly, up to 10 years

  7. 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

    Time frame: yearly, up to 10 years

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

    presence or absence of endometriosis

    Time frame: baseline

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

    presence or absence of polycystic ovary

    Time frame: baseline

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

    presence or absence of uterine fibroma

    Time frame: baseline

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

    presence or absence of hormonal therapy

    Time frame: baseline

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

    date of first period

    Time frame: baseline

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

    number of pregnancy

    Time frame: baseline

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

    number of children

    Time frame: baseline

  15. 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)

    Time frame: baseline

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

    absence or presence of menopause

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Nov 2039, 183 months after the start.

Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 183 months is above that.

Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2024
First posted
Apr 3, 2024
StartActual
Jul 15, 2024
Primary completionEst.
Nov 1, 2039
CompletionEst.
Sep 1, 2040
Last update
Feb 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06343844
Responsible party
Sponsor
First posted
Apr 3, 2024
Start date
Jul 15, 2024
Primary completion
Nov 1, 2039 (estimated)
Completion
Sep 1, 2040 (estimated)
Last update
Feb 9, 2026

Study contacts

LOIC BIERE, PHD
Contact
LoBiere@chu-angers.fr
02 41 35 36 37 ext. +33
VIVIANE CASSISA
Contact
DRCI-Promotion-Interne@chu-angers.fr
02 41 35 36 37 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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