Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
NCT05762601
Summary
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.
Eligibility
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
Conditions5
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NCT05762601