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Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction

Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04058782
Acronym
RIGID-MI
Enrollment
2000
Registered
2019-08-16
Start date
2020-02-17
Completion date
2030-03-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Myocardial Infarction, Vascular Stiffness

Keywords

Prognosis, Vascular stiffness, Heart failure, Myocardial infarction

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.

Interventions

OTHERImaging 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

Sponsors

University Hospital, Lille
Lead SponsorOTHER
Fédération Française de Cardiologie
CollaboratorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
MACE: Major adverse cardiovascular eventsat 5 yearsA composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, acute limb ischemia, coronary revascularization, hospitalization for heart failure

Secondary

MeasureTime frameDescription
Cardiovascular deathat 5 years
Myocardial infarctionat 5 years
Ischemic strokeat 5 years
Systemic embolismat 5 years
Acute limb ischemiaat 5 years
Coronary revascularizationat 5 years
Hospitalization for heart failureat 5 years
All-cause deathat 5 years
Bleeding as assessed by Bleeding Academic Research Consortium (BARC)at 5 years
Bleeding as assessed by GUSTO Bleeding Criteriaat 5 yearsGlobal Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) definition for bleeding range to 1. Severe or Life-threatening/ 2. Moderate/ 3. Mild
Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteriaat 5 years
Bleeding as assessed by ISTH definitionsat 5 years

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGilles Lemesle, MD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026