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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03617601
Other study ID # KEK-ZH-Nr: 2017-00801
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2009
Est. completion date January 2018

Study information

Verified date July 2018
Source Triemli Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 296
Est. completion date January 2018
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MET
Testing of the metabolic equivalent of task before aortic procedure

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Triemli Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Mean survival during the whole follow up period of both groups, patients with less and more than 4 MET up to ten years
Secondary Perioperative complications Complications include perioperative myocardial infarction and stroke, re-operation during first admission (divided in greater and smaller re-operations) up to 30 days postoperatively
Secondary Coronary artery bypass grafting, percutaneous coronary intervention/Stenting Interventions including revascularisation or other kind of heart surgery or treatment because of cardiac pathology up to ten years
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