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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03276-49 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Fédération Française de Cardiologie | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with myocardial |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging evaluation for vascular assessment | Other | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | at 5 years | |
| Myocardial infarction | at 5 years | |
| Ischemic stroke |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Lemesle, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Coeur-Poumon, CHU | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Blood sample for total blood, plasma and peripheral blood mononuclear cell collection at 1-month.
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| 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 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |