Cardiovascular DiseasesVICTORNCT01812343
Value of Ankle Pressure Index After Maximal Exercise Tests
A study testing Exercise test in people with Cardiovascular Diseases, run by University Hospital, Angers at 1 site in France.
Trial summary
Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease. Estimate morbi-mortality of included patients over a 5 years follow up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2009to 11 May 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and more
Who cannot join
- patient with recent cardiovascular event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesure de l'Index de Pression Systolique de Cheville après Test d'Effort Maximal.
Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease.
Estimate morbi-mortality of included patients over a 5 years follow up.
- Conditions
- Cardiovascular Diseases
- Being tested
- Exercise test
- Keywords
- Ankle Brachial Index, Maximal Exercise Test
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise test | Other | Ankle pressure Index measure before and after Maximal Exercise Tests Receives: Other: Exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of post exercise ABI by age categories
Ankle to brachial index is measured before and after a maximal exercise on a cycle ergometer. results are expressed by age categories of 10 years interval
Measured: up to 15min
Secondary outcomes (1)
Prevalence of Morbi-mortality through self completed questionnaires
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study start17 Sep 2009
- Primary completion11 May 2020
- Study completion11 May 2020
Why it stopped: Inclusions objectives raised but patient follow-up reduced to 6 months (impossible to raised secondary objectives)
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, PU-PH, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812343
- Sponsor's protocol ID
- PHRC-2011
- Acronym
- VICTOR
- Status last verified
- Nov 2019
- First submitted
- 4 Mar 2013
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Congnard F, Abraham P, Vincent F, Le Tourneau T, Carre F, Hupin D, Hamel JF, Vielle B, Bruneau A. Ankle to brachial systolic pressure index at rest increases with age in asymptomatic physically active participants. BMJ Open Sport Exerc Med. 2015 Nov 25;1(1):e000081. doi: 10.1136/bmjsem-2015-000081. eCollection 2015.
PubMed 27900144
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesure de l'Index de Pression Systolique de Cheville après Test d'Effort Maximal.
- ClinicalTrials.gov ID
- NCT01812343
- Acronym / sponsor ID
- VICTOR / PHRC-2011
- Conditions
- Cardiovascular Diseases
- Keywords
- Ankle Brachial Index, Maximal Exercise Test
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusions objectives raised but patient follow-up reduced to 6 months (impossible to raised secondary objectives)
- Enrolment
- 1,760 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 17 Sep 2009 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 18 Mar 2013 (estimated)
- 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.
Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease.
Estimate morbi-mortality of included patients over a 5 years follow up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise test | Other | Other: Exercise testAnkle pressure Index measure before and after Maximal Exercise Tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years old and more
Key exclusion criteria (1 listed)
- patient with recent cardiovascular event
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 |
|---|---|---|
| Exercise test | Other | Exercise test |
Primary outcome
Mean value of post exercise ABI by age categories
Time frame: up to 15min
Ankle to brachial index is measured before and after a maximal exercise on a cycle ergometer. results are expressed by age categories of 10 years interval
1 secondary outcome
Prevalence of Morbi-mortality through self completed questionnaires
Time frame: up to 5 year
Results and safety
The study was stopped early (reason given: Inclusions objectives raised but patient follow-up reduced to 6 months (impossible to raised secondary objectives)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Derived from this study: PubMed 27900144Congnard F, Abraham P, Vincent F, Le Tourneau T, Carre F, Hupin D, Hamel JF, Vielle B, Bruneau A. Ankle to brachial systolic pressure index at rest increases with age in asymptomatic physically active participants. BMJ Open Sport Exerc Med. 2015 Nov 25;1(1):e000081. doi: 10.1136/bmjsem-2015-000081. eCollection 2015.
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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.
Pierre ABRAHAM, PU-PH principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise test in people with Cardiovascular Diseases, run by University Hospital, Angers 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 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: stopped early, as of the sponsor's last update on 2 Aug 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 was stopped early (reason given: Inclusions objectives raised but patient follow-up reduced to 6 months (impossible to raised secondary objectives)). Results are not available in the source record.
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?
Mean value of post exercise ABI by age categories (time frame: up to 15min). 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 NCT01812343, 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 2 Aug 2022.