Circulating miR-126 as a Novel Biomarker for Post Myocardial Infarction Remodeling

Study Overview
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Brief Summary
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Purpose: The purpose of this study is to evaluate the impact of circulating miR-126 on left ventricular remodeling and clinical outcomes in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Official Title
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Impact of Circulating miR-126 on Left Ventricular Remodeling and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention. The PMIR-miR-126 Study.

Conditions
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Myocardial Infarction, Left Ventricular Remodeling, miR-126

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; Age ≥18 years; Informed consent from patient or next of kin. Exclusion Criteria: Nonischaemic Cardiomyopathy; Cardiac surgery planed in the 6 months; Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); Renal or hepatic failure; Malignancy, HIV, or central nervous system disorder; Cardiopulmonary resuscitation >15 min and compromised level of consciousness; Cardiogenic shock; Current participation in any research study involving investigational drugs or devices; No written consensus; Previous myocardial infarction.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High miR-126 group<br> | |
| Moderate miR-126 group<br> | |
| Low miR-126 group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LVEDV from baseline by 3D-echocardiogram | The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) at 6 months post-PCI by 3D-echocardiogram. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Cardiovascular death, myocardial infarction, target vessel revascularization,recurrent ischaemia, heart failure | 6 months | 
| All cause mortality |  | 6 months | 
| Stent thrombosis |  | 6 months | 
| Change in LVESV from baseline | Change from baseline in left ventricular end systolic volume (LVESV), ejection fraction (LVEF) and mass at 6 months post-PCI by 3D-echocardiogram | 6 months | 
| NT-proBNP levels |  | at 1 and 180 days post-PCI | 
| Incidence of complete ST-segment resolution |  | 3 hours after PCI | 
| Peak troponin T level |  | 24 hours after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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miR-126, Left Ventricular Remodeling, Myocardial Infarction, primary percutaneous coronary intervention, left ventricular end diastolic volume, left ventricular ejection fraction, major adverse cardiovascular events