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NCT05762601
Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
Conditions: Cardiac Complication, Myocardial Infarction, Myocardial Ischemia, Myocardial Injury
Sex: All
Ages: 45 Years – N/A
Enrollment: 12
Sponsor: Ottawa Hospital Research Institute
Location: Canada
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 doneComplete some surveysHave two echocardiograms (ultrasounds of the heart)Continue to follow-up with the research team for one year after their surgeryResearchers 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 Criteria
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 olderRevised cardiac risk index ≥ 2NT-proBNP level of ≥ 200 pg/mLAble to provide informed consentExclusion Criteria:Experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 monthsCoronary revascularization anticipated during the study periodSevere mitral/aortic valve stenosisEvidence of clinically significant arrhythmia in last three months.Major surgical procedure in previous 3 monthsHistory of malignancy requiring surgery, chemotherapy, immunotherapy, or radiation within previous 5 yearsOngoing malignancy requiring surgical resectionWomen who are pregnant, breastfeeding, or of childbearing potential who are unable to use a medically acceptable form of contraception throughout the studyReceived any experimental cell therapy previouslyUnable to provide written informed consent
Source: ClinicalTrials.gov (NCT05762601). StuddyBuddy aggregates publicly available trial information.