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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT01317095
Eligibility Criteria:
Inclusion Criteria:
1. scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
2. patient age ≥18 and \<80 .
3. patient undergoing elective surgery.
4. patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)
5. patients who is willing to sign the informed consent to participate the study.
Exclusion Criteria:
Pre- operative exclusion criteria:
1. patient undergoing redo-sternotomy.
2. patient undergoing emergent surgery (defined as life-threatening or unstable condition requiring surgery on the same day of the surgical consultation.)
3. patients on dialysis
4. patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
5. patients with body mass index ≥ 40.
6. patients with active endocarditis.
7. patients with known metal allergy.
8. patient who refuses consent.
9. patient who is unable to follow the postoperative instructions.
Intraoperative exclusion criteria:
1. osteoporosis or poor quality of sternum.
2. unstable sternal fracture.
3. sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.
4. bilateral mammary artery harvest (causing poor blood supply to the sternum).
5. patients in whom the chest needs to be left open due to medical reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01317095
Study Brief:
Protocol Section:
NCT01317095