Aortic DiseasesNCT03617601
Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
An observational study of Aortic Diseases, run by Triemli Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Diseases
- What is being tested?
- MET
- How many people
- 296 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 296 patients who received an aortic repair with open or endovascular technique at Triemli Hospital from May 2009 till March 2016
Who may be able to join
- Data of all patients after open and endovascular aortic repair of the descending aorta from May 2009 till March 2016
Who cannot join
- Data of all patients with isolated operations on the ascending aorta or aortic arch
About this study
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.
- Conditions
- Aortic Diseases
- Being tested
- MET
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METDiagnostic test
Testing of the metabolic equivalent of task before aortic procedure
| Study group | Role | What they receive |
|---|---|---|
| > 4 MET | Patients with functional capacity over 4 MET Receives: Diagnostic Test: MET | |
| < 4 MET | Patients with functional capacity under 4 MET Receives: Diagnostic Test: MET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Mean survival during the whole follow up period of both groups, patients with less and more than 4 MET
Measured: up to ten years
Secondary outcomes (2)
Perioperative complications
Complications include perioperative myocardial infarction and stroke, re-operation during first admission (divided in greater and smaller re-operations)
Measured: up to 30 days postoperatively
Coronary artery bypass grafting, percutaneous coronary intervention/Stenting
Interventions including revascularisation or other kind of heart surgery or treatment because of cardiac pathology
Measured: up to ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startMay 2009
- Primary completionAug 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicja Zientara, Triemli Hospital
- Investigators
- Nicolas Attigah, MD, Study chair, Triemli Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617601
- Sponsor's protocol ID
- KEK-ZH-Nr: 2017-00801
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33714271
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
- ClinicalTrials.gov ID
- NCT03617601
- Acronym / sponsor ID
- KEK-ZH-Nr: 2017-00801
- Conditions
- Aortic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| > 4 MET | – | Diagnostic Test: METPatients with functional capacity over 4 MET |
| < 4 MET | – | Diagnostic Test: METPatients with functional capacity under 4 MET |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 296 patients who received an aortic repair with open or endovascular technique at Triemli Hospital from May 2009 till March 2016
Key inclusion criteria (1 listed)
- Data of all patients after open and endovascular aortic repair of the descending aorta from May 2009 till March 2016
Key exclusion criteria (1 listed)
- Data of all patients with isolated operations on the ascending aorta or aortic arch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| METTesting of the metabolic equivalent of task before aortic procedure | Diagnostic test | < 4 MET, > 4 MET |
Primary outcome
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
2 secondary outcomes
Perioperative complications
Time frame: up to 30 days postoperatively
Coronary artery bypass grafting, percutaneous coronary intervention/Stenting
Time frame: up to ten years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Derived from this study: PubMed 33714271Zientara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Attigah, MD study chair
Triemli Hospital Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Diseases, run by Triemli Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: up to ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.