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
NCT number | NCT02860754 |
Other study ID # | 5392 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 7, 2016 |
Est. completion date | December 2019 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
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 |
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