CClinicalTrials.gg
Status unknownNCT02860754Updated Mar 14, 2019

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

An interventional study of Six-minute walk test to perform before surgery in Noncardiac Surgery, Postoperative Myocardial Infarction and Postoperative Death, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed description

Study investigators propose to undertake a prospective cohort study at the preoperative clinics of the Royal-Victoria and Montreal General Hospitals of McGill University Health Centre. All patients with planned noncardiac surgery under general or regional anesthesia will be considered for inclusion.

Eligible consenting patients will undergo the 6MWT during their preoperative clinical visit, typically occurring within a few weeks before surgery. This test will be performed by a trained health care worker. Patients will walk back and forth along a 20 m corridor, while attempting to cover as much ground as possible in 6 minutes. Patients will be allowed to rest on the chairs while performing the test if necessary. Patients will be encouraged to resume walking as soon as patients feel physically able. The total covered distance in 6 minutes will be measured to the nearest meter.

The RCRI score will be calculated for each study participant.

02

Conditions studied

  • Noncardiac Surgery
  • Postoperative Myocardial Infarction
  • Postoperative Death
  • Risk Assessment
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Other
    Six-minute walk test

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

    Other: Six-minute walk test to perform before surgery

Interventions

  • OtherSix-minute walk test to perform before surgery

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

06

What researchers measure

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.

    Time frame: At 30 day after surgery

Secondary outcomes

  1. Compare self reported MET score to 6MWT distance

    Determine whether the MET score reported by the patient is comparable to the MET score derived from the 6MWT distance covered.

    Time frame: At preoperative clinic visit. Only one measure

07

Study locations

1 of 1 sites recruiting
  • McGill University Health Center
    Montreal, Quebec H4A 3J1, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02860754
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Amal Bessissow, MD (Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Aug 9, 2016
Start date
Sep 7, 2016
Primary completion
Jun 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Mar 14, 2019

Study contacts

Amal Bessissow, MD
Contact
amal.bessissow@mcgill.ca
514-934-1934 ext. 45722
Amal Bessissow, MD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion