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

NCT05160311 | Unknown

• 1 other identifier: 5106
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Myocardial Dysfunction; Percutaneous Coronary Intervention

Keywords

STEMI; myocardial viability; Late percutaneous coronary intervention; myocardial remodelling; Myocardial reperfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Assessement of Left Ventricle Ejection Fraction (LVEF)

  6 months

• Assessement of Myocardial contractility

  6 months

• Evaluate Quality of Life

  6 months

• Acute MI Event

  6 months

• Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)

  6 months

Study Arms (2)

Optimized Medical Treatment (OMT)

OTHER

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)

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

EXPERIMENTAL

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); Device: Drug Eluting Stent (DES) Coronary Angioplasty

Interventions

Optimized Medical Treatment (OMT) DRUG

Optimized Medical Drug Treatment

Angioplasty (PCI) and Optimized Medical Treatment (OMT); Optimized Medical Treatment (OMT)

Drug Eluting Stent (DES) Coronary Angioplasty DEVICE

Percutaneous Angioplasty with DES

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012909, Brazil

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Drug-Eluting Stents; Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies; Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Barbara Valente, MD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Valente, MD

CONTACT

5585988083444; barbaravalente@hotmail.com

Pedro Farsky, MD, PhD

CONTACT

5511991662309; pedro.farsky@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Physician

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 16, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)