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

Instituto Dante Pazzanese de Cardiologia70 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

STEMI - ST Elevation Myocardial Infarction Myocardial Dysfunction Percutaneous Coronary Intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Assessement of Left Ventricle Ejection Fraction (LVEF)

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.

Time frame: 6 months

Assessement of Myocardial contractility

Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI.

Time frame: 6 months

Evaluate Quality of Life

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.

Time frame: 6 months

Acute MI Event

Incidence of Acute Myocardial Infarct.

Time frame: 6 months

Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)

Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge

Time frame: 6 months

Cardiovascular Death

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).

Time frame: 6 months

Cardiovascular-Related Hospitalization

Incidence of New Cardiovascular related Hospitalization after discharge

Time frame: 6 months

Stroke Event

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).

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts