NCT04058782

Brief Summary

Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. The RIGID-MI study proposes to deeply evaluate at 1 month after MI: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. The main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of MI, and bleeding.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Feb 2020Mar 2030

First Submitted

Initial submission to the registry

August 7, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

February 17, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

August 7, 2019

Last Update Submit

April 21, 2026

Conditions

Heart FailureMyocardial InfarctionVascular Stiffness

Keywords

PrognosisVascular stiffnessHeart failureMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • MACE: Major adverse cardiovascular events

    A composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, acute limb ischemia, coronary revascularization, hospitalization for heart failure

    at 5 years

Secondary Outcomes (12)

  • Cardiovascular death

    at 5 years

  • Myocardial infarction

    at 5 years

  • Ischemic stroke

    at 5 years

  • Systemic embolism

    at 5 years

  • Acute limb ischemia

    at 5 years

  • +7 more secondary outcomes

Study Arms (1)

Patients with myocardial

Other: Imaging evaluation for vascular assessment

Interventions

Imaging evaluation for vascular assessmentOTHER

At 1month after MI, Blood sample for total blood, plasma and PBMC collection, ECG, 3D-trans thoracic echocardiography for ventriculo-arterial coupling assessment, Vascular doppler for peripheral artery disease assessment, Arterial stiffness evaluation, Bilateral transcranial doppler for HITS evaluation

Patients with myocardial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. Over a 5-year period of time from 2019 to 2024. Planned population of 2000 patients. Follow-up every year by visit or phone contact up to 5 years.

You may qualify if:

  • Signed informed consent
  • Affiliated to national health insurance (French social security number)
  • Presenting with MI within 48 hours of symptom onset

You may not qualify if:

  • Patient under curatorship
  • Type 2 MI
  • Presenting with MI after 48 hours of symptom onset
  • Pregnancy or lactating
  • Refuse to participate
  • No national health insurance (No French social security number)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Coeur-Poumon, CHU

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for total blood, plasma and peripheral blood mononuclear cell collection at 1-month.

MeSH Terms

Conditions

Myocardial InfarctionHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Gilles Lemesle, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 16, 2019

Study Start

February 17, 2020

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations

FR(1)