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

NCT ID: NCT02860754

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-07

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Noncardiac Surgery Postoperative Myocardial Infarction Postoperative Death Risk Assessment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Six-minute walk test

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

Group Type OTHER

Six-minute walk test to perform before surgery

Intervention Type OTHER

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

Interventions

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Six-minute walk test to perform before surgery

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Amal Bessissow, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Bessissow, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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McGill University Health Center

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Amal Bessissow, MD

Role: CONTACT

514-934-1934 ext. 45722

Facility Contacts

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Amal Bessissow, MD

Role: primary

5149341934 ext. 53333

Other Identifiers

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5392

Identifier Type: -

Identifier Source: org_study_id

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