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

Instituto Dante Pazzanese de Cardiologia

Status: Enrolling

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

Treatments: Device: Drug Eluting Stent (DES) Coronary Angioplasty; Drug: Optimized Medical Treatment (OMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05160311

5106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

3.3 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Optimized Medical Treatment (OMT)

Other group

Description:

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)

Treatment:

Drug: Optimized Medical Treatment (OMT)

Angioplasty (PCI) and Optimized Medical Treatment (OMT)

Experimental group

Description:

The patient considered non-viable and randomized to Coronary Angioplasty will be treated with drug-eluting stent (PCI) and Optimized Medical Treatment (OMT)

Treatment:

Device: Drug Eluting Stent (DES) Coronary Angioplasty

Drug: Optimized Medical Treatment (OMT)