Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Complication
- Sponsor
- Ottawa Hospital Research Institute
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Baseline Frequency of adverse events and serious adverse events
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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 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
Outcomes
Primary Outcomes
Baseline Frequency of adverse events and serious adverse events
Time Frame: 1 year
To determine the baseline frequency of adverse events and serious adverse events in this high risk population
Feasibility of Participant Recruitment
Time Frame: 1 year
Our primary outcome is the feasibility of participant recruitment. This will be determined by measurements of recruitment efficiency: 1) proportion of potentially eligible participants that are successfully screened; 2) proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded).
Secondary Outcomes
- Quality of life of participants(1 year)