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

Risk Assessment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02860754
• Other study ID #: 5392
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: McGill University Health Center
• Contact: Amal Bessissow, MD
• Phone: 514-934-1934
• Email: amal.bessissow[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Six-minute walk test to perform before surgery
During the outpatient preoperative assessment, eligible patients will perform the six-minute walk test.

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At preoperative clinic visit. Only one measure