AnesthesiaMET-REPAIR ValNCT04132947
Validity of the MET-REPAIR Questionnaire
An observational study of Anesthesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
MET-REPAIR CONVAL is an international cohort study to examine the ability of self-reported exercise capacity to predict perioperative cardiovascular events correcting for preoperative risk factors. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Anesthesia
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2019to 28 Feb 2020
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients admitted to the ambulatory cardiology ward
Who may be able to join
- over 45 years of age
- clinically indicated exercise testing
- signed written informed consent
Who cannot join
- unable to complete the questionnaire
- unable to consent or unwilling to participate
- cancelled exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MET-REPAIR CONVAL: Concurrent Validity of the MET-REPAIR Questionnaire in German and of the Duke Activity Scale Index for Estimating Exercise Capacity Measured Using Exercise Testing
MET-REPAIR CONVAL is an international cohort study to examine the ability of self-reported exercise capacity to predict perioperative cardiovascular events correcting for preoperative risk factors.
- Conditions
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Cohort Study correlating self reported exercise activity and spiroergometry results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic equivalents (METs)
METs per spiroergometry; assessment at time of clinically mandated spiroergometry
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Nov 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eckhard Mauermann, Dr. med. MD, Principal investigator, University Hospital Basel, Dep. of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132947
- Sponsor's protocol ID
- 2018-01930
- Other IDs
- 2018
- Acronym
- MET-REPAIR Val
- Status last verified
- Feb 2020
- First submitted
- 16 Oct 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MET-REPAIR CONVAL: Concurrent Validity of the MET-REPAIR Questionnaire in German and of the Duke Activity Scale Index for Estimating Exercise Capacity Measured Using Exercise Testing
- ClinicalTrials.gov ID
- NCT04132947
- Acronym / sponsor ID
- MET-REPAIR Val / 2018-01930
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Oct 2019 (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.
MET-REPAIR CONVAL is an international cohort study to examine the ability of self-reported exercise capacity to predict perioperative cardiovascular events correcting for preoperative risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Cohort Study correlating self reported exercise activity and spiroergometry results |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients admitted to the ambulatory cardiology ward
Key inclusion criteria (3 listed)
- over 45 years of age
- clinically indicated exercise testing
- signed written informed consent
Key exclusion criteria (3 listed)
- unable to complete the questionnaire
- unable to consent or unwilling to participate
- cancelled exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic equivalents (METs)
Time frame: at Baseline
METs per spiroergometry; assessment at time of clinically mandated spiroergometry
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 2 Mar 2020.
- 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.
Eckhard Mauermann, Dr. med. MD principal investigator
University Hospital Basel, Dep. of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 3 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Metabolic equivalents (METs) (time frame: at Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2020.