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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00463294
Eligibility Criteria:
Inclusion Criteria:
Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they:
1. require isolated CABG with median sternotomy
2. are able to give their informed written consent
3. are\> 21 years of age and
4. have one or more of the following risk factors:
* ≥ 70 years
* peripheral vascular disease (previous peripheral bypass or amputation or ABI \<0.80)
* Cerebrovascular disease (history of stroke, TIA)
* Renal insufficiency (creatinine above upper limit of normal)
* \>60 years of age and one of the following:
* diabetes (oral hypoglycemic agent and/or insulin)
* urgent revascularization (waiting in hospital)
* LV ejection fraction \<35%
* current or recent smoker.
* 55-59 years of age and two of the following:
* diabetes (oral hypoglycemic agent and/or insulin)
* urgent revascularization (waiting in hospital)
* LV ejection fraction \<35%
* current or recent smoker.
Exclusion Criteria:
Patients will be excluded if they have one of the following:
1. concomitant cardiac procedure associated with CABG,
2. contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
3. concomitant life-threatening disease likely to limit life expectancy to less than 2 years,
4. prior enrollment in this trial
5. emergency CABG surgery (immediate revascularization for hemodynamic instability) OR
6. redo CABG.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00463294
Study Brief:
Protocol Section:
NCT00463294