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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT06841757
Eligibility Criteria:
Inclusion Criteria:
* All adult patients scheduled for elective isolated on-pump CABG surgery for two- to three-vessel coronary artery disease.
* Both males and females will be included.
* In the diabetic groups: Type II diabetes currently requiring and adhering to insulin therapy for at least the past 3 months
* During cardiopulmonary bypass, the temperature will range from 28-33°C using an esophageal temperature probe.
* Antegrade warm cardioplegia will be given by the cardiovascular perfusionist.
* Baseline diastolic function will be obtained preoperatively using transthoracic echocardiography done within the six months prior to the surgery
Exclusion Criteria:
* Combined CABG and valve surgery, emergency CABG.
* Type I diabetes, Type 2 diabetes managed with oral hypoglycemic agents without insulin in the past 3 months
* Peripheral vascular disease (PVD) affecting the upper limbs.
* Acute coronary syndrome (ACS); acute or recent myocardial infarction.
* Left ventricular ejection fraction ≤30%.
* Serious pulmonary disease necessitating oxygen supplementation or mechanical ventilation.
* Renal failure, defined as eGFR \< 30 mL/min/1.73 m² or requiring renal replacement therapy (dialysis).
* Liver failure, including Child-Pugh Class B or C cirrhosis, severe hepatocellular dysfunction, or listed for liver transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06841757
Study Brief:
Protocol Section:
NCT06841757