Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05762601

Conditions

Cardiac Complication

Myocardial Infarction

Myocardial Ischemia

Myocardial Injury

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cardiac Complication

Myocardial Infarction

Myocardial Ischemia

Myocardial Injury

Study ID

NCT05762601

Start date

Feb 15, 2023

Status verified date

Apr, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Feasibility of Participant Recruitment [ Time Frame: 1 year ]
  • Baseline Frequency of adverse events and serious adverse events [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Meredith Conboy, MSc

613-737-8899mconboy@ohri.ca

Manoj M Lalu, MD, PhD

613-737-8899mlalu@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Principal Investigator:

Manoj M Lalu, MD, PhD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • Myocardial injury after noncardiac surgery
  • Perioperative myocardial infarction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-04-03.