- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617601
Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
Reliable prediction of the preoperative risk is of crucial importance for patients undergoing vascular operations. The assessment of the metabolic equivalent of task (MET) is an easy clinical evaluation of the functional capacity of an individual. A MET is defined as the resting metabolic rate, that is the amount of the consumed oxygen at rest. According to the MET concept a patient would be considered as "fit for surgery" when the stairs of two flights can be climbed and the housework can be fully managed by oneself.
Hypothesis: Patients with a functional capacity over 4 MET (fit for surgery) have less perioperative complications with the focus on cardiac pathology than patients with less than 4 MET during aortic operations.
Patients and Method: Retrospective analysis of a single center unit of 296 patients undergoing open or endovascular aortic repair.
Study Overview
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Data of all patients after open and endovascular aortic repair of the descending aorta from May 2009 till March 2016
Exclusion Criteria:
- Data of all patients with isolated operations on the ascending aorta or aortic arch
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
> 4 MET
Patients with functional capacity over 4 MET
|
Testing of the metabolic equivalent of task before aortic procedure
|
< 4 MET
Patients with functional capacity under 4 MET
|
Testing of the metabolic equivalent of task before aortic procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: up to ten years
|
Mean survival during the whole follow up period of both groups, patients with less and more than 4 MET
|
up to ten years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perioperative complications
Time Frame: up to 30 days postoperatively
|
Complications include perioperative myocardial infarction and stroke, re-operation during first admission (divided in greater and smaller re-operations)
|
up to 30 days postoperatively
|
Coronary artery bypass grafting, percutaneous coronary intervention/Stenting
Time Frame: up to ten years
|
Interventions including revascularisation or other kind of heart surgery or treatment because of cardiac pathology
|
up to ten years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nicolas Attigah, MD, Triemli Hospital Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr: 2017-00801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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