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

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

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.

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