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

Recruiting

• Conditions: Vascular Stiffness; Heart Failure; Myocardial Infarction
• Interventions: Other: Imaging evaluation for vascular assessment

• Registration Number: NCT04058782
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-16
• Study Start: 2020-02-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with myocardial	Imaging evaluation for vascular assessment	-

Primary Outcome Measures

Name	Time	Method
MACE: Major adverse cardiovascular events	at 5 years	A composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, acute limb ischemia, coronary revascularization, hospitalization for heart failure

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	at 5 years
Myocardial infarction	at 5 years
Systemic embolism	at 5 years
All-cause death	at 5 years
Bleeding as assessed by GUSTO Bleeding Criteria	at 5 years	Global 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) criteria	at 5 years
Ischemic stroke	at 5 years
Bleeding as assessed by ISTH definitions	at 5 years
Acute limb ischemia	at 5 years
Coronary revascularization	at 5 years
Hospitalization for heart failure	at 5 years
Bleeding as assessed by Bleeding Academic Research Consortium (BARC)	at 5 years

Trial Locations

Locations (1)

Institut Coeur-Poumon, CHU; 🇫🇷 Lille, France