NCT05762601

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

February 8, 2023

Last Update Submit

April 2, 2024

Conditions

Cardiac ComplicationMyocardial InfarctionMyocardial IschemiaMyocardial Injury

Keywords

Myocardial injury after noncardiac surgeryPerioperative myocardial infarction

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (1)

  • Quality of life of participants

    1 year

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from the Ottawa Hospital

You may qualify if:

  • 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)
  • years of age or older
  • Revised cardiac risk index ≥ 2
  • NT-proBNP level of ≥ 200 pg/mL
  • Able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30255989BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only plasma will be retained.

MeSH Terms

Conditions

Myocardial InfarctionMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Manoj M Lalu, MD, PhD

    The Ottawa Hospital Research Institute, The Ottawa Hospital, University of Ottawa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith Conboy, MSc

CONTACT

613-737-8899mconboy@ohri.ca

Manoj M Lalu, MD, PhD

CONTACT

613-737-8899mlalu@toh.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 9, 2023

Study Start

February 15, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

April 3, 2024

Record last verified: 2024-04

Locations

CA(1)