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

Not Applicable

• Conditions: STEMI - ST Elevation Myocardial Infarction; Myocardial Dysfunction; Percutaneous Coronary Intervention
• Interventions: Drug: Optimized Medical Treatment (OMT); Device: Drug Eluting Stent (DES) Coronary Angioplasty

• Registration Number: NCT05160311
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-10-29
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2022-01-11
• Primary Completion: 2023-12-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimized Medical Treatment (OMT)	Optimized Medical Treatment (OMT)	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)
Angioplasty (PCI) and Optimized Medical Treatment (OMT)	Optimized Medical Treatment (OMT)	The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)
Angioplasty (PCI) and Optimized Medical Treatment (OMT)	Drug Eluting Stent (DES) Coronary Angioplasty	The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)

Primary Outcome Measures

Name	Time	Method
Reverse myocardial remodeling after late recanalization in patients without viability	6 months	Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI

Secondary Outcome Measures

Name	Time	Method
Assessement of Myocardial contractility	6 months	Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI.
Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)	6 months	Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge
Stroke Event	6 months	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).
Assessement of Left Ventricle Ejection Fraction (LVEF)	6 months	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.
Cardiovascular Death	6 months	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).
Evaluate Quality of Life	6 months	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.
Acute MI Event	6 months	Incidence of Acute Myocardial Infarct.
Cardiovascular-Related Hospitalization	6 months	Incidence of New Cardiovascular related Hospitalization after discharge

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo, Brazil