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

Recruiting

• Conditions: Myocardial Ischemia; Myocardial Injury; Cardiac Complication; Myocardial Infarction

• Registration Number: NCT05762601
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study First Submitted: 2023-02-08
• Study Start: 2023-02-15
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada