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

Heart Failure Clinical Trial

— RIGID-MI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058782
• Other study ID #: 2018_43
• Secondary ID: 2018-A03276-49
• Status: Recruiting
• Start date: February 17, 2020
• Est. completion date: March 2030

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Gilles Lemesle, MD
• Phone: 03 20 44 45 61
• Email: gilles.lemesle[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction
• Vascular Stiffness

Intervention

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

Locations

Country	Name	City	State
France	Institut Coeur-Poumon, CHU	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Fédération Française de Cardiologie, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular death		at 5 years
Secondary	Myocardial infarction		at 5 years
Secondary	Ischemic stroke		at 5 years
Secondary	Systemic embolism		at 5 years
Secondary	Acute limb ischemia		at 5 years
Secondary	Coronary revascularization		at 5 years
Secondary	Hospitalization for heart failure		at 5 years
Secondary	All-cause death		at 5 years
Secondary	Bleeding as assessed by Bleeding Academic Research Consortium (BARC)		at 5 years
Secondary	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
Secondary	Bleeding as assessed by Thrombolysis in Myocardial Infarction (TIMI) criteria		at 5 years
Secondary	Bleeding as assessed by ISTH definitions		at 5 years