Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction (RIGID-MI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Heart Failure; Vascular Stiffness
• Intervention / Treatment: Other: Imaging evaluation for vascular assessment

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Institut Coeur-Poumon, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with myocardial	Other: Imaging evaluation for vascular assessment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Coronary revascularization		at 5 years
Hospitalization for heart failure		at 5 years
All-cause death		at 5 years
Bleeding as assessed by Bleeding Academic Research Consortium (BARC)		at 5 years
Bleeding as assessed by GUSTO Bleeding Criteria	Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) definition for bleeding range to 1. Severe or Life-threatening/ 2. Moderate/ 3. Mild	at 5 years
Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria		at 5 years
Bleeding as assessed by ISTH definitions		at 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Merck Sharp & Dohme LLC; Fédération Française de Cardiologie
• Investigators: Principal Investigator: Gilles Lemesle, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prognosis; Heart failure; Myocardial infarction; Vascular stiffness
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Heart Failure; Myocardial Infarction
• Other Study ID Numbers: 2018_43; 2018-A03276-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No