NCT03617601

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
Last Updated

August 6, 2018

Status Verified

July 1, 2018

Enrollment Period

7.3 years

First QC Date

July 6, 2018

Last Update Submit

August 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Perioperative complications

    up to 30 days postoperatively

  • Coronary artery bypass grafting, percutaneous coronary intervention/Stenting

    up to ten years

Study Arms (2)

> 4 MET

Patients with functional capacity over 4 MET

Diagnostic Test: MET

< 4 MET

Patients with functional capacity under 4 MET

Diagnostic Test: MET

Interventions

METDIAGNOSTIC_TEST

Testing of the metabolic equivalent of task before aortic procedure

< 4 MET> 4 MET

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

296 patients who received an aortic repair with open or endovascular technique at Triemli Hospital from May 2009 till March 2016

You may qualify if:

  • Data of all patients after open and endovascular aortic repair of the descending aorta from May 2009 till March 2016

You may not qualify if:

  • Data of all patients with isolated operations on the ascending aorta or aortic arch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zientara A, Schwegler I, Dzemali O, Bruijnen H, Bernheim A, Dick F, Attigah N. Evaluation of metabolic equivalents of task (METs) in the preoperative assessment in aortic repair. BMC Surg. 2021 Mar 13;21(1):130. doi: 10.1186/s12893-021-01143-0.

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Nicolas Attigah, MD

    Triemli Hospital Zurich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident for cardiac surgery

Study Record Dates

First Submitted

July 6, 2018

First Posted

August 6, 2018

Study Start

May 1, 2009

Primary Completion

August 1, 2016

Study Completion

January 1, 2018

Last Updated

August 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share