Observational study on heart complications after non-heart surgery
Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
This study looks at people who are at high risk for heart problems to see how often these issues happen after non-heart surgeries and gathers health information for future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05762601 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather health data from individuals at high risk for heart complications undergoing non-cardiac surgeries. It will assess the feasibility of recruiting participants and the frequency of heart complications in this population. Participants will receive standard care, undergo additional blood tests, complete surveys, and have echocardiograms, with follow-up for one year post-surgery. The data collected will serve as a control group for a future study involving stem cell treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older, referred for elective intermediate to high-risk non-cardiac surgery with specific cardiac risk factors.
Not a fit: Patients who have experienced recent acute coronary events or have significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of heart complications in high-risk surgical patients, potentially leading to better preventive strategies.
How similar studies have performed: While this approach is observational, similar studies have shown promise in understanding perioperative risks, though this specific methodology is less common.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Manoj M Lalu, MD, PhD — The Ottawa Hospital Research Institute, The Ottawa Hospital, University of Ottawa
- Study coordinator: Meredith Conboy, MSc
- Email: mconboy@ohri.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.