Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery

• Sponsor: Triemli Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03617601
• Collaborator: (none)
• Enrollment: 296
• Actual Duration (Months): 104

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases	Diagnostic Test: MET

Study Design

• Study Type: Observational
• Actual Enrollment: 296 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
• Actual Study Start Date: May 1, 2009
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
> 4 MET Patients with functional capacity over 4 MET	Diagnostic Test: MET; Testing of the metabolic equivalent of task before aortic procedure
< 4 MET Patients with functional capacity under 4 MET	Diagnostic Test: MET; Testing of the metabolic equivalent of task before aortic procedure

Outcome Measures

Primary Outcome Measures

1. Survival [up to ten years]

   Mean survival during the whole follow up period of both groups, patients with less and more than 4 MET

Secondary Outcome Measures

1. Perioperative complications [up to 30 days postoperatively]

   Complications include perioperative myocardial infarction and stroke, re-operation during first admission (divided in greater and smaller re-operations)

2. Coronary artery bypass grafting, percutaneous coronary intervention/Stenting [up to ten years]

   Interventions including revascularisation or other kind of heart surgery or treatment because of cardiac pathology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Triemli Hospital

Investigators

• Study Chair: Nicolas Attigah, MD, Triemli Hospital Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alicja Zientara, Resident for cardiac surgery, Triemli Hospital
• ClinicalTrials.gov Identifier: NCT03617601
• Other Study ID Numbers: KEK-ZH-Nr: 2017-00801
• First Posted: Aug 6, 2018
• Last Update Posted: Aug 6, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Diseases

Study Results

No Results Posted as of Aug 6, 2018