Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study (COSMIC)

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Myocardial Ischemia; Cardiac Complication; Myocardial Infarction; Myocardial Injury

Study type: Observational

Funder types: Other

Identifiers

NCT05762601

20220330-01H

Details and patient eligibility

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:

• 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.

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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