The primary objective is to determine to which extent the MET score as estimated by the MET-REPAIR questionnaire correlates to the physical capacity level as measured by the 6MWT.The secondary objective is to determine to which extent the following…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Distance walked within 6 minutes in meters (6 minute walk test)
Secondary outcome
NA
Background summary
Adverse cardiac events are an important complication of noncardiac surgery.A
core component to estimate the perioperative cardiac risk is an estimation of
the cardiovascular functional capacity expressed as metabolic equivalents
(METs). Cardiopulmonary exercise testing provides a good objective measure of
the MET score, which in turn is a strong predictor of postoperative outcome.
However, for practical reasons METs are usually estimated by self-reported
functional capacity. However, in contrast to measured METs, the evidence on
estimated METs and outcome after noncardiac surgery is limited and not
conclusive.
Therefore, a prospective cohort study is initiated by the European Society of
Anesthesiology to study the predictive value of the MET score as estimated by a
questionnaire on major adverse cardiovascular events or cardiovascular
mortality (MET REPAIR study, NCT03016936).
Regarding this questionnaire, it is important to study to which extent the
estimated MET score correlates to the actual measured functional capacity.
Study objective
The primary objective is to determine to which extent the MET score as
estimated by the MET-REPAIR questionnaire correlates to the physical capacity
level as measured by the 6MWT.
The secondary objective is to determine to which extent the following items
from the MET REPAIR questionnaire correlate with the 6MWT:
- Self-reported number of floors that can be climbed without having to stop to
rest
- Self-reported rating of cardiorespiratory fitness as compared to the
patients* peers
- Self-reported daily/weekly physical activity.
Study design
Prospective cohort study
Study burden and risks
The burden of participation consist of the 6-minute walk test. The risk of this
6 minute walk test is considered minimal. Although there is no direct benefit
for individual participants, the potential benefit for assessing perioperative
cardiac risk in non-cardiac surgery for future patients is considerable.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Noncardiac surgical patients at high risk of perioperative cardiac complications, defined by:
- 45 years of age or older and Revised Cardiac Risk Index * 2, OR
- aged *65 years and undergoing intermediate or high-risk procedures
Participation in MET-REPAIR study (NCT03016936)
Exclusion criteria
* Non-elective surgery
* Acute coronary syndrome or uncontrolled congestive heart failure within the last 30 days
* Stroke within the last 7 days of planned day of surgery
* Patients unable to perform ambulation
* Minors or legally incompetent subjects
* Patients unable or unwilling to participate
* Previous enrollment in this study (in case of repeated surgery within duration of the study)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL63436.041.17 |