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Clinical Trials/NCT05160311
NCT05160311
Unknown
N/A

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

Instituto Dante Pazzanese de Cardiologia1 site in 1 country70 target enrollmentAugust 1, 2021

Overview

Phase
N/A
Intervention
Optimized Medical Treatment (OMT)
Conditions
STEMI - ST Elevation Myocardial Infarction
Sponsor
Instituto Dante Pazzanese de Cardiologia
Enrollment
70
Locations
1
Primary Endpoint
Reverse myocardial remodeling after late recanalization in patients without viability
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Porto Valente

Cardiology Physician

Instituto Dante Pazzanese de Cardiologia

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

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)

Intervention: Optimized Medical Treatment (OMT)

Angioplasty (PCI) and 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)

Intervention: Optimized Medical Treatment (OMT)

Angioplasty (PCI) and 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)

Intervention: Drug Eluting Stent (DES) Coronary Angioplasty

Outcomes

Primary Outcomes

Reverse myocardial remodeling after late recanalization in patients without viability

Time Frame: 6 months

Evaluate reverse remodeling after late recanalization in patients without viability measuring End Systolic Volume (ESV) by MRI

Secondary Outcomes

  • Assessement of Myocardial contractility(6 months)
  • Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)(6 months)
  • Stroke Event(6 months)
  • Assessement of Left Ventricle Ejection Fraction (LVEF)(6 months)
  • Cardiovascular Death(6 months)
  • Evaluate Quality of Life(6 months)
  • Acute MI Event(6 months)
  • Cardiovascular-Related Hospitalization(6 months)

Study Sites (1)

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