Trials / Recruiting
RecruitingNCT05762601
Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (estimated)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are: * Is this study feasible in terms of recruiting enough people to participate in this study? * How often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart? Participants will have their usual care and will also be asked to: * Have extra bloodwork done * Complete some surveys * Have two echocardiograms (ultrasounds of the heart) * Continue to follow-up with the research team for one year after their surgery Researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.
Detailed description
This observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming Phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in the same patient population. Participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study.
Conditions
Timeline
- Start date
- 2023-02-15
- Primary completion
- 2024-09-01
- Completion
- 2025-09-01
- First posted
- 2023-03-09
- Last updated
- 2024-04-03
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05762601. Inclusion in this directory is not an endorsement.