Recruiting

Observational Study

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT02860754

Conditions

Noncardiac Surgery

Postoperative Myocardial Infarction

Postoperative Death

Risk Assessment

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Six-minute walk test to perform before surgery

Study Details

Brief summary:

This prospective cohort study aims to determine whether the addition of the 6MWT to the RCRI score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac surgery. In addition, this study will assess whether the patients' reported MET score corresponds to the determined MET score from the 6MWT distance completed.

Conditions

Noncardiac Surgery

Postoperative Myocardial Infarction

Postoperative Death

Risk Assessment

Study ID

NCT02860754

Start date

Sep 7, 2016

Status verified date

Mar, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All patients fulfilling all the following inclusion criteria will be enrolled:

  • Patients aged ≥ 50 year old and undergoing elective noncardiac surgery, under general anesthesia or regional anesthesia.
  • Patients with planned surgery within 3 months of the preoperative visit.

Patients with at least one of the following medical conditions:

  • Hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, transient ischemic attack, stroke, or peripheral vascular disease.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

  • Patients with a condition preventing mobilization for 6 minutes.
  • Patients with significant cardiac disease (e.g., low-threshold angina (angina that occurs with minimal exertion), severe aortic stenosis).
  • Patients with severe pulmonary disease restricting mobility.
  • Patients refusing to participate.
  • Patients previously enrolled in the study.

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Six-minute walk test

All patients will perform six-minute walk test before surgery, in the preoperative clinic

Interventions

Six-minute walk test to perform before surgery

During the outpatient preoperative assessment, eligible patients will perform the six-minute walk test.

Primary outcome measure

  • Measure the additive prognostic value of 6MWT to the RCRI score [ Time Frame: At 30 day after surgery ]

Central Contacts and Locations

Central contacts

Amal Bessissow, MD

514-934-1934amal.bessissow@mcgill.ca

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Amal Bessissow, MD

5149341934amal.bessissow@mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 14, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2019-03-14.