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

NCT ID: NCT05160311

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Optimized Medical Treatment (OMT)

Intervention Type: DRUG

Optimized Medical Drug Treatment

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)

Group Type: EXPERIMENTAL

Optimized Medical Treatment (OMT)

Intervention Type: DRUG

Optimized Medical Drug Treatment

Drug Eluting Stent (DES) Coronary Angioplasty

Intervention Type: DEVICE

Percutaneous Angioplasty with DES

Interventions

Optimized Medical Treatment (OMT)

Optimized Medical Drug Treatment

Intervention Type: DRUG

Drug Eluting Stent (DES) Coronary Angioplasty

Percutaneous Angioplasty with DES

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. STEMI not reperfused between 24 hours and 28 days

2. MI-related artery with > or = 50%

3. Segmental dysfunction in the artery related to infarction.

4. Technical feasibility for PCI recanalization

5. Absence of Myocardial Viability

Exclusion Criteria

1. Age > 80 years

2. < 1 year life expectancy

3. Post MI Angina

4. Clinical Instability

5. Electrical Instability

6. Previous Infarction with segment disfunction

7. New York Heart Association (NYHA) class III or IV of heart failure.

8. Previous diagnosis of congestive heart failure or cardiomyopathy

9. Severe heart valve disease

10. Absence of segmental dysfunction in the artery related to infarction

11. Coronary angiography without obstructive lesions

12. Indication of myocardial revascularization surgery

13. Opted for clinical treatment for technical reasons

14. Serum creatinine concentration greater than 2.5 mg/dl

15. Pacemaker or Implantable Cardiodefibrillator (ICD)

16. Brain Clip Carriers

17. Patients with Cochlear Implants

18. Refusal to sign the Informed Consent Form (ICF).

19. Inability to maintain outpatient follow-up for 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: lead

Responsible Party

Barbara Porto Valente

Cardiology Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Valente, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Barbara Valente, MD

Role: CONTACT

barbaravalente@hotmail.com

5585988083444

Pedro Farsky, MD, PhD

Role: CONTACT

pedro.farsky@gmail.com

5511991662309

Facility Contacts

BARBARA VALENTE, MD

Role: primary

BARBARAVALENTE@HOTMAIL.COM

551150856204

RENATA VIANA, MD

Role: backup

RVIANA@DANTEPAZZANESE.ORG.BR

551150856204

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Other Identifiers

5106

Identifier Type: -

Identifier Source: org_study_id