The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery

NCT02860754 | Unknown

• 1 other identifier: 5392
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Measure the additive prognostic value of 6MWT to the RCRI score

  Investigate the additive prognostic value of the 6MWT to the RCRI score for predicting major cardiovascular complications at 30 day after surgery, in patients undergoing noncardiac surgery.

  At 30 day after surgery

Secondary Outcomes (1)

• Compare self reported MET score to 6MWT distance

  At preoperative clinic visit. Only one measure

Study Arms (1)

Six-minute walk test

OTHER

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

Other: Six-minute walk test to perform before surgery

Interventions

Six-minute walk test to perform before surgery OTHER

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

Six-minute walk test

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Study Officials

• Amal Bessissow, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Bessissow, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: August 9, 2016
• Study Start: September 7, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

CA (1)