Cardiovascular DiseasesVAQARNCT04163731
VAlidation of an Self Administered Questionnaire in French for Assessment of Cardio Respiratory Reserve
An observational study of Cardiovascular Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The guidelines of the European Society of Cardiology (ESC) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (VO2peak) one of the cornerstones of preoperative evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- DASI questionnaire
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2020to 11 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All stable patients above 18 years, referred for a VO2 peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon) and without acute clinical event in the last 3 months.
Who may be able to join
- Major patients
- Patients considered stable according to the judgment of the investigator
- Indication of a stress test with measurement of VO2max as part of its medical management
Who cannot join
- Acute clinical event in the last 3 months
- System Illness Context
- Absence of coverage by a social security system
- Safeguarding justice (tutelage, guardianship, deprivation of civil rights)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
The guidelines of the European Society of Cardiology (ESC) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (VO2peak) one of the cornerstones of preoperative evaluation.
Indeed, below a certain threshold of VO2 peak fixed in the literature at 15 milliliters/kilogram/minutes (ml/kg/min) (or 4 Metabolic Equivalent of Task - MET), the ESC recommends to carry out additional non-invasive examinations to evaluate the coronary risk of these patients.
Read more
In current practice, this evaluation is performed in anesthesia consultation by non-standard interview. The question "Can you go up a floor or climb a hill?" permits to classify patients with more or less VO2 peak than 4 MET.
However, several studies, including one published in the Lancet in 2018, show that this evaluation doesn't assess correctly the VO2peak of the patients nor predict post-operative cardiac complications.
In the same study, the evaluation of a standardized self-questionnaire, the Duke Activity Status Index (DASI), found a good correlation between the value of this pre-operative score and the 30-day mortality as well as the occurrence of infarction.
This self-questionnaire contains a dozen questions about the physical activities of daily life that patients are able or not to perform (household, various physical activity). It has also been validated in medical patients as being well correlated with the value of VO2 peak in the case of an answer by a third party (r = 0.81, p <0.001) and satisfactory in the case of a self-questionnaire (r = 0.58 , p <0.001).
This self-questionnaire exists in English but there is no validated translation in French. Given the cultural differences, it seems necessary in order to use it in a French-speaking context to go through a scientific validation stage. A validation study of DASI in Portuguese has already been published recently, serving as a methodological basis for a French translation.
The purpose of this study is to carry out a validation of a standardized self-questionnaire in French. It will be distributed to patients referred for a VO2peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon). The results of VO2peak predicted by the self-questionnaire will be compared to the VO2 peak measured during the examination.
- Conditions
- Cardiovascular Diseases
- Being tested
- DASI questionnaire
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASI questionnaireOther
All patients who accept to participate will undergo a self-questionnaire of 10 minutes. Medical data of their cardiac stress test and risk factor will be collected.
| Study group | Role | What they receive |
|---|---|---|
| stable patient, referred for a VO2 peak test | All stable patients above 18 years, referred for a VO2 peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon) and without acute clinical event in the last 3 months. All patients who accept to participate will undergo a self-questionnaire of 10 minutes. Receives: Other: DASI questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capacity of the DASI self-questionnaire
Sensitivity and specificity of the DASI self-questionnaire translated into French to identify patients with a threshold of VO2max <14 milliliters (mL) O2 kilogram-1 minute-1 measured during the exercise test.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start18 May 2020
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163731
- Sponsor's protocol ID
- 69HCL19_0409
- Other IDs
- 2019-A02629-48
- Acronym
- VAQAR
- Status last verified
- Mar 2022
- First submitted
- 12 Nov 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAlidation of an Self Administered Questionnaire in French for Assessment of Cardio Respiratory Reserve
- ClinicalTrials.gov ID
- NCT04163731
- Acronym / sponsor ID
- VAQAR / 69HCL19_0409
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 15 Nov 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.
The guidelines of the European Society of Cardiology (ESC) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (VO2peak) one of the cornerstones of preoperative evaluation.
Indeed, below a certain threshold of VO2 peak fixed in the literature at 15 milliliters/kilogram/minutes (ml/kg/min) (or 4 Metabolic Equivalent of Task - MET), the ESC recommends to carry out additional non-invasive examinations to evaluate the coronary risk of these patients.
In current practice, this evaluation is performed in anesthesia consultation by non-standard interview. The question "Can you go up a floor or climb a hill?" permits to classify patients with more or less VO2 peak than 4 MET.
However, several studies, including one published in the Lancet in 2018, show that this evaluation doesn't assess correctly the VO2peak of the patients nor predict post-operative cardiac complications.
In the same study, the evaluation of a standardized self-questionnaire, the Duke Activity Status Index (DASI), found a good correlation between the value of this pre-operative score and the 30-day mortality as well as the occurrence of infarction.
This self-questionnaire contains a dozen questions about the physical activities of daily life that patients are able or not to perform (household, various physical activity). It has also been validated in medical patients as being well correlated with the value of VO2 peak in the case of an answer by a third party (r = 0.81, p <0.001) and satisfactory in the case of a self-questionnaire (r = 0.58 , p <0.001).
This self-questionnaire exists in English but there is no validated translation in French. Given the cultural differences, it seems necessary in order to use it in a French-speaking context to go through a scientific validation stage. A validation study of DASI in Portuguese has already been published recently, serving as a methodological basis for a French translation.
The purpose of this study is to carry out a validation of a standardized self-questionnaire in French. It will be distributed to patients referred for a VO2peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon). The results of VO2peak predicted by the self-questionnaire will be compared to the VO2 peak measured during the examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stable patient, referred for a VO2 peak test | – | Other: DASI questionnaireAll stable patients above 18 years, referred for a VO2 peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon) and without acute clinical event in the last 3 months. All patients who accept to participate will undergo a self-questionnaire of 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All stable patients above 18 years, referred for a VO2 peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon) and without acute clinical event in the last 3 months.
Key inclusion criteria (3 listed)
- Major patients
- Patients considered stable according to the judgment of the investigator
- Indication of a stress test with measurement of VO2max as part of its medical management
Key exclusion criteria (5 listed)
- Acute clinical event in the last 3 months
- System Illness Context
- Absence of coverage by a social security system
- Safeguarding justice (tutelage, guardianship, deprivation of civil rights)
- Pregnant or lactating women
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 |
|---|---|---|
| DASI questionnaireAll patients who accept to participate will undergo a self-questionnaire of 10 minutes. Medical data of their cardiac stress test and risk factor will be collected. | Other | stable patient, referred for a VO2 peak test |
Primary outcome
Capacity of the DASI self-questionnaire
Time frame: Day 0
Sensitivity and specificity of the DASI self-questionnaire translated into French to identify patients with a threshold of VO2max <14 milliliters (mL) O2 kilogram-1 minute-1 measured during the exercise test.
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 4 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Diseases, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 4 Mar 2022. 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 France. 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?
Capacity of the DASI self-questionnaire (time frame: Day 0). 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 4 Mar 2022.