RIGID-MI: Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [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]
- Bleeding as assessed by ISTH definitions [at 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent
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Affiliated to national health insurance (French social security number)
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Presenting with MI within 48 hours of symptom onset
Exclusion Criteria:
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Patient under curatorship
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Type 2 MI
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Presenting with MI after 48 hours of symptom onset
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Pregnancy or lactating
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Refuse to participate
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No national health insurance (No French social security number)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Coeur-Poumon, CHU | Lille | France | 59037 |
Sponsors and Collaborators
- University Hospital, Lille
- Fédération Française de Cardiologie
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Gilles Lemesle, MD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018_43
- 2018-A03276-49