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.
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.
Study Type
OBSERVATIONAL
Enrollment
12
The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGFeasibility of Participant Recruitment
Our primary outcome is the feasibility of participant recruitment. This will be determined by measurements of recruitment efficiency: 1) proportion of potentially eligible participants that are successfully screened; 2) proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded).
Time frame: 1 year
Baseline Frequency of adverse events and serious adverse events
To determine the baseline frequency of adverse events and serious adverse events in this high risk population
Time frame: 1 year
Quality of life of participants
The EQ-5D-5L questionnaire will be used. This questionnaire measures quality of life using five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Time frame: 1 year
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