Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study

Conditions
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Cardiac Complication, Myocardial Infarction, Myocardial Ischemia, Myocardial Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A participant must meet all 5 inclusion criteria to be eligible: Referred for elective intermediate to high risk noncardiac surgery as defined by the American Heart Association guidelines (e.g., intrathoracic, open intraabdominal, or open vascular surgery) 45 years of age or older Revised cardiac risk index ≥ 2 NT-proBNP level of ≥ 200 pg/mL Able to provide informed consent Exclusion Criteria: Experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 months Coronary revascularization anticipated during the study period Severe mitral/aortic valve stenosis Evidence of clinically significant arrhythmia in last three months. Major surgical procedure in previous 3 months History of malignancy requiring surgery, chemotherapy, immunotherapy, or radiation within previous 5 years Ongoing malignancy requiring surgical resection Women who are pregnant, breastfeeding, or of childbearing potential who are unable to use a medically acceptable form of contraception throughout the study Received any experimental cell therapy previously Unable to provide written informed consent

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility 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). | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial injury after noncardiac surgery, Perioperative myocardial infarction