Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT04011059
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT04011059
Study Brief:
Protocol Section:
NCT04011059