Peripheral Vascular DiseasesNCT01076738
Screening DIVA - Diffuse Vascular Disease
An observational study of Peripheral Vascular Diseases, run by Sanofi at 1 site in Canada.
Trial summary
Primary Objective: To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- How many people
- 2,233 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Jun 2010
- 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: Patients with documented ACS or/and IS / TIA
Who may be able to join
- Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA)
Who cannot join
- Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record):
- Non-invasive or invasive vascular diagnostic tools (e.g.: ABI, Toe-brachial index, Duplex ultrasound, Magnetic resonance angiography, Computer tomographic angiography, Contrast angiography)
- Previous related intervention (such as angioplasty, stenting, atherectomy, peripheral arterial bypass graft, other vascular intervention including amputation)
- Patients whose ABI cannot be measured accurately
- Patients already in a clinical trial or a product registry
- Hospitalized patients
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Routine Screening for Diffuse Vascular Disease in the Canadian Post-Acute Coronary Syndrome/Ischemic Stroke/Transient Ischemic Attack General Practice Population With Previously Undocumented Peripheral Arterial Disease
Primary Objective:
To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have peripheral arterial disease (PAD) at the time of enrolment.
Secondary Objective:
To collect data on the prevalence of PAD in this population as measured by ABI.
- Conditions
- Peripheral Vascular Diseases
- Medical subject headings
- Peripheral Vascular Diseases
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 |
|---|---|---|
| single group study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity and specificity of the ECQ versus ABI.
Measured: within 12 (+/- 2) weeks
Secondary outcomes (2)
To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9)
Measured: within 12 (+/- 2) weeks
To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9)
Measured: within 12 (+/- 2) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJun 2010
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 Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 2,233 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Medical Affairs, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076738
- Sponsor's protocol ID
- DIREG_L_04222
- Status last verified
- Sep 2010
- First submitted
- 25 Feb 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
Publications
Bell AD, Roussin A, Popovici-Toma D, Girard M, Chiu JF, Huckell V. The value of routine screening for peripheral arterial disease in stable outpatients with a history of coronary artery or cerebrovascular disease. Int J Clin Pract. 2013 Oct;67(10):996-1004. doi: 10.1111/ijcp.12148. Epub 2013 May 21.
PubMed 23692499
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Routine Screening for Diffuse Vascular Disease in the Canadian Post-Acute Coronary Syndrome/Ischemic Stroke/Transient Ischemic Attack General Practice Population With Previously Undocumented Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01076738
- Acronym / sponsor ID
- DIREG_L_04222
- Conditions
- Peripheral Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,233 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Feb 2010 (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.
Primary Objective:
To investigate the value of the Edinburgh Claudication Questionnaire (ECQ) against the ankle-brachial index (ABI) in Canadian patients mainly followed in general practice, with documented acute coronary syndrome (ACS)/ischemic stroke (IS)/transient ischemic attack (TIA) and who are not known to have peripheral arterial disease (PAD) at the time of enrolment.
Secondary Objective:
To collect data on the prevalence of PAD in this population as measured by ABI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group study | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with documented ACS or/and IS / TIA
Key inclusion criteria (1 listed)
- Documented acute coronary syndrome (Unstable angina, non-Q-wave myocardial infarction, Q-wave myocardial infarction) or/and documented ischemic stroke/transient ischemic attack (IS/TIA)
Key exclusion criteria (7 listed)
- Previously known symptomatic or asymptomatic PAD confirmed by one of the following diagnostic methods or interventions (documented in the patient's medical record):
- Patients whose ABI cannot be measured accurately
- Patients already in a clinical trial or a product registry
- Hospitalized patients
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
To determine the sensitivity and specificity of the ECQ versus ABI.
Time frame: within 12 (+/- 2) weeks
2 secondary outcomes
To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9)
Time frame: within 12 (+/- 2) weeks
To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9)
Time frame: within 12 (+/- 2) weeks
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 13 Sep 2010.
- Derived from this study: PubMed 23692499Bell AD, Roussin A, Popovici-Toma D, Girard M, Chiu JF, Huckell V. The value of routine screening for peripheral arterial disease in stable outpatients with a history of coronary artery or cerebrovascular disease. Int J Clin Pract. 2013 Oct;67(10):996-1004. doi: 10.1111/ijcp.12148. Epub 2013 May 21.
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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.
Medical Affairs study director
Sanofi
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 Peripheral Vascular Diseases, run by Sanofi at 1 site in Canada.
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 7 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 13 Sep 2010. 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 Canada. 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?
To determine the sensitivity and specificity of the ECQ versus ABI. (time frame: within 12 (+/- 2) weeks). 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 NCT01076738, 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 13 Sep 2010.