Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance Image (MRI) can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months.

Detailed Description
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The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months and through the improvement in segmental contractility of infarcted related artery at MRI.

Official Title
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Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

Conditions
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STEMI - ST Elevation Myocardial Infarction, Myocardial Dysfunction, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Optimized Medical Treatment (OMT)
* Device: Drug Eluting Stent (DES) Coronary Angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria STEMI not reperfused between 24 hours and 28 days MI-related artery with > or = 50% Segmental dysfunction in the artery related to infarction. Technical feasibility for PCI recanalization Absence of Myocardial Viability 3.3 Exclusion criteria Age > 80 years < 1 year life expectancy Post MI Angina Clinical Instability Electrical Instability Previous Infarction with segment disfunction New York Heart Association (NYHA) class III or IV of heart failure. Previous diagnosis of congestive heart failure or cardiomyopathy Severe heart valve disease Absence of segmental dysfunction in the artery related to infarction Coronary angiography without obstructive lesions Indication of myocardial revascularization surgery Opted for clinical treatment for technical reasons Serum creatinine concentration greater than 2.5 mg/dl Pacemaker or Implantable Cardiodefibrillator (ICD) Brain Clip Carriers Patients with Cochlear Implants Refusal to sign the Informed Consent Form (ICF). Inability to maintain outpatient follow-up for 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who had underestimated STEMI with more than 24 hours up to 28 days referred by the Cross System (Central For Regulation of Health Services Supply) and the Campo Limpo Hospital (Co-participant Center) will be admitted sequentially for coronary angiography in the hemodynamics sector of the Instituto Dante Pazzanese de Cardiologia (IDPC) from August 2021 to February 2023.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optimized Medical Treatment (OMT)<br>The patient considered non-viable by MRI and randomized to Optimized Medical Treatment (OMT) will be treated according to Optimized Medical Treatment guidelines for Coronary Artery Disease (CAD) | Drug: Optimized Medical Treatment (OMT)<br>* Optimized Medical Drug Treatment<br>|
| Experimental: Angioplasty (PCI) and Optimized Medical Treatment (OMT)<br>The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT) | Drug: Optimized Medical Treatment (OMT)<br>* Optimized Medical Drug Treatment<br>Device: Drug Eluting Stent (DES) Coronary Angioplasty<br>* Percutaneous Angioplasty with DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reverse myocardial remodeling after late recanalization in patients without viability | Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessement of Left Ventricle Ejection Fraction (LVEF) | Change in LVEF measured by MRI The degree of LVEF recovery after a MI provides important prognostic information. Patients with no recovery in LVEF after MI are at high risk of sudden cardiac arrest events and death. | 6 months | 
| Assessement of Myocardial contractility | Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI. | 6 months | 
| Evaluate Quality of Life | Evaluate change from baseline in patients Quality of life using Abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire. The WHOQOL-Bref (Field Trial Version) produces a profile with four domain scores and two individually scored items about an individual's overall perception of quality of life and health. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The possible raw score ranges for each domain are as follows: Physical Health=28, Psychological=24, Social Relationships=12, and Environment=32. | 6 months | 
| Acute MI Event | Incidence of Acute Myocardial Infarct. | 6 months | 
| Unplanned revascularization (Ischemia Driven and Not Ischemia Driven) | Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge | 6 months | 
| Cardiovascular Death | Incidence of Cardiovascular Death. Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). | 6 months | 
| Cardiovascular-Related Hospitalization | Incidence of New Cardiovascular related Hospitalization after discharge | 6 months | 
| Stroke Event | Incidence of Stroke Event Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, myocardial viability, Late percutaneous coronary intervention, myocardial remodelling, Myocardial reperfusion