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| Name | Class |
|---|---|
| Canadian Anesthesiologists' Society | OTHER |
| The Ottawa Hospital Academic Medical Association | OTHER |
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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:
Participants will have their usual care and will also be asked to:
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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Participant Recruitment | 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). | 1 year |
| Baseline Frequency of adverse events and serious adverse events | To determine the baseline frequency of adverse events and serious adverse events in this high risk population | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of participants | The EQ-5D-5L questionnaire will be used. This questionnaire measures quality of life using five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. | 1 year |
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Inclusion Criteria:
A participant must meet all 5 inclusion criteria to be eligible:
Exclusion Criteria:
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Participants will be recruited from the Ottawa Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meredith Conboy, MSc | Contact | 613-737-8899 | 73800 | mconboy@ohri.ca |
| Manoj M Lalu, MD, PhD | Contact | 613-737-8899 | 75083 | mlalu@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Manoj M Lalu, MD, PhD | The Ottawa Hospital Research Institute, The Ottawa Hospital, University of Ottawa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30255989 | Background | Lalu MM, Mazzarello S, Zlepnig J, Dong YYR, Montroy J, McIntyre L, Devereaux PJ, Stewart DJ, David Mazer C, Barron CC, McIsaac DI, Fergusson DA. Safety and Efficacy of Adult Stem Cell Therapy for Acute Myocardial Infarction and Ischemic Heart Failure (SafeCell Heart): A Systematic Review and Meta-Analysis. Stem Cells Transl Med. 2018 Dec;7(12):857-866. doi: 10.1002/sctm.18-0120. Epub 2018 Sep 26. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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Only plasma will be retained.
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |