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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04038294
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 60 years of age or older, undergoing elective isolated CABG, aortic valve repair or replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair or replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures.
2. Patients with a Clinical Frailty Score (CFS) from 3 (Managing Well) to 7 (severely frail),
3. Patients with a Short Physical Performance Battery (SPPB) score of 9 or less, or an SF-36 (PF) score of \<= 60
4. Patients with an estimated wait time for elective cardiac surgery of 1 week or longer
5. Inpatients with an estimated wait time for non-emergent cardiac surgery of 2 days or longer from hospital admission
Exclusion Criteria:
1. Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
2. Patients with a Clinical Frailty Score (CFS) of 7 or greater (Severely frail to terminally ill); this will exclude less than 1% of the population on the elective cardiac surgery waitlist.
3. Creatinine clearance \<30 mL/min/1.83 m2
4. Cirrhosis (Child-Pugh Class B or greater)
5. Allergy to milk proteins or other ingredients in the supplement
6. Inability to safely ingest beverage by mouth
7. Significant cognitive impairment (MoCA Score \< 16)
8. An inability to speak/read in English or French
9. Non-emergent or emergent surgery less than 2 days from hospital admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04038294
Study Brief:
Protocol Section:
NCT04038294