Status:
UNKNOWN
Randomized Study of Coronary Revascularization Surgery With Injection of WJ-MSCs and Placement of an Epicardial Extracellular Matrix
Lead Sponsor:
Hospital San Vicente Fundación
Collaborating Sponsors:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
IPS Universitaria Servicios de Salud Universidad de Antioquia
Conditions:
Cardiovascular Diseases
Heart Failure
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Ischemic heart disease is one of the most important causes of mortality and morbidity in the Western world and is a public health problem. Among ischemic heart diseases, myocardial infarction has spec...
Detailed Description
A randomized clinical trial will be conducted as a proof of concept in 40 patients with previous myocardial infarction and a viable myocardial zone with indications for coronary artery bypass grafts. ...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of coronary disease, performed by coronary angiography, requiring conventional coronary revascularization surgery
- History of myocardial infarction; evidence of akinesia or regional dyskinesia more than 1 week old
- Ejection fraction less than 40%
- Age between 30 and 75 years
- Negative serology for HIV, hepatitis B virus (HBV), and hepatitis C virus HCV
- Negative pregnancy test for women of childbearing age
- Patients who sign the informed consent complying with all of the provisions of current regulations in Colombia
Exclusion
- History of myocardial infarction with ST-segment elevation within 2 weeks prior to surgery
- History of myocardial infarction without ST-segment elevation within the previous week (the decision to include these patients within the first week after suffering a non-ST elevation infarction is at the discretion of the research team)
- Previous history of tachycardia or ventricular fibrillation
- History of active neoplasia or previous chemotherapy treatment
- Severe or uncontrolled concomitant disease (i.e., poorly controlled chronic kidney or liver failure)
- Patients who, due to their place of residence, mental health or social situation, have difficulty meeting the conditions of the protocol
- Women who are pregnant or breast-feeding
- Patients or legal representatives withdrawing informed consent at any time during the study.
- Previous history of heart transplant
- Patients with functional organ impairment: liver function: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase greater than 2 times the upper reference limit; kidney function: serum creatinine \> 1.5 mg/dl or creatinine clearance \< 60 ml/min.
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04011059
Start Date
July 2 2019
End Date
June 30 2023
Last Update
July 9 2019
Active Locations (1)
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1
Hospital San Vicente Fundación
Medellín, Antioquia, Colombia