Clinical trial NCT05762601: Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
Official title: Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Complication
Myocardial Infarction
Myocardial Ischemia
Myocardial Injury
Keywords: Myocardial injury after noncardiac surgery
Perioperative myocardial infarction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Anesthesiologists' Society
name: The Ottawa Hospital Academic Medical Association
First posted: 2023-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the Ottawa Hospital

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.

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

Primary outcomes:
measure: Feasibility of Participant Recruitment
timeFrame: 1 year
measure: Baseline Frequency of adverse events and serious adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life of participants
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Research Institute, The Ottawa Hospital, University of Ottawa
name: Manoj M Lalu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.