Clinical trial NCT05160311: Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility
Official title: Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Myocardial Dysfunction
Percutaneous Coronary Intervention
Keywords: STEMI
myocardial viability
Late percutaneous coronary intervention
myocardial remodelling
Myocardial reperfusion
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Reverse myocardial remodeling after late recanalization in patients without viability
timeFrame: 6 months
Secondary outcomes:
measure: Assessement of Left Ventricle Ejection Fraction (LVEF)
timeFrame: 6 months
measure: Assessement of Myocardial contractility
timeFrame: 6 months
measure: Evaluate Quality of Life
timeFrame: 6 months
measure: Acute MI Event
timeFrame: 6 months
measure: Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)
timeFrame: 6 months
measure: Cardiovascular Death
timeFrame: 6 months
measure: Cardiovascular-Related Hospitalization
timeFrame: 6 months
measure: Stroke Event
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Barbara Valente, MD
role: PRINCIPAL_INVESTIGATOR
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