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About
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:
Participants will have their usual care and will also be asked to:
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.
Full 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.
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Inclusion criteria
A participant must meet all 5 inclusion criteria to be eligible:
Exclusion criteria
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Central trial contact
Manoj M Lalu, MD, PhD; Meredith Conboy, MSc
Data sourced from clinicaltrials.gov
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