Screening DIVA - Diffuse Vascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01076738
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : September 13, 2010
Bristol-Myers Squibb
Information provided by:

February 25, 2010
February 26, 2010
September 13, 2010
April 2009
June 2010   (Final data collection date for primary outcome measure)
To determine the sensitivity and specificity of the ECQ versus ABI. [ Time Frame: within 12 (+/- 2) weeks ]
Same as current
Complete list of historical versions of study NCT01076738 on Archive Site
  • 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 ]
Same as current
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Screening DIVA - Diffuse Vascular Disease
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.

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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with documented ACS or/and IS / TIA
Peripheral Vascular Diseases
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single group study
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Medical Affairs study director, sanofi-aventis
Bristol-Myers Squibb
Study Director: Medical Affairs Sanofi
September 2010