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

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160311
• Other study ID #: 5106
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2021
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: Barbara Valente, MD
• Phone: 5585988083444
• Email: barbaravalente[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Dysfunction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• Optimized Medical Treatment (OMT)
Optimized Medical Drug Treatment

Device:
• Drug Eluting Stent (DES) Coronary Angioplasty
Percutaneous Angioplasty with DES

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Country where clinical trial is conducted

Brazil, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months
Secondary	Assessement of Myocardial contractility	Evaluate the change of reverse LV remodeling after late recanalization assessed by MRI.	6 months
Secondary	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.	6 months
Secondary	Acute MI Event	Incidence of Acute Myocardial Infarct.	6 months
Secondary	Unplanned revascularization (Ischemia Driven and Not Ischemia Driven)	Incidence of Unplanned Myocardial revascularization (Ischemia Driven and Not Ischemia Driven) after hospital discharge	6 months
Secondary	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).	6 months
Secondary	Cardiovascular-Related Hospitalization	Incidence of New Cardiovascular related Hospitalization after discharge	6 months
Secondary	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).	6 months