COSMIC: Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05762601

Collaborator

Canadian Anesthesiologists' Society (Other), The Ottawa Hospital Academic Medical Association (Other)

Enrollment

Location

23.6

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Complication Myocardial Infarction Myocardial Ischemia Myocardial Injury

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study

Actual Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Outcome Measures

Primary Outcome Measures

Feasibility of Participant Recruitment [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).
Baseline Frequency of adverse events and serious adverse events [1 year]
To determine the baseline frequency of adverse events and serious adverse events in this high risk population

Secondary Outcome Measures

Quality of life of participants [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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