Back to resultsThe Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery
Primary Purpose
Noncardiac Surgery, Postoperative Myocardial Infarction, Postoperative Death
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Six-minute walk test to perform before surgery
Sponsored by
About this trial
This is an interventional prevention trial for Noncardiac Surgery
Eligibility Criteria
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.
Sites / Locations
- McGill University Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Six-minute walk test
Arm Description
All patients will perform six-minute walk test before surgery, in the preoperative clinic
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02860754
First Posted
April 14, 2016
Last Updated
March 13, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT02860754
Brief Title
The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery
Official Title
The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery: Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2016 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noncardiac Surgery, Postoperative Myocardial Infarction, Postoperative Death, Risk Assessment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Six-minute walk test
Arm Type
Other
Arm Description
All patients will perform six-minute walk test before surgery, in the preoperative clinic
Intervention Type
Other
Intervention Name(s)
Six-minute walk test to perform before surgery
Intervention Description
During the outpatient preoperative assessment, eligible patients will perform the six-minute walk test.
Primary Outcome Measure Information:
Title
Measure the additive prognostic value of 6MWT to the RCRI score
Description
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 Outcome Measure Information:
Title
Compare self reported MET score to 6MWT distance
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Bessissow, MD
Phone
514-934-1934
Ext
45722
Email
amal.bessissow@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Bessissow, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Bessissow, MD
Phone
5149341934
Ext
53333
Email
amal.bessissow@mcgill.ca
12. IPD Sharing Statement
Learn more about this trial
The Prognostic Capabilities Of A Preoperative Six-Minute Walk Test To Independently Inform Cardiovascular Risk After Major Noncardiac Surgery
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