Screening DIVA – Diffuse Vascular Disease

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2010

Arms, Groups and Cohorts

  • single group study

Clinical Trial Outcome Measures

Primary Measures

  • To determine the sensitivity and specificity of the ECQ versus ABI.
    • Time Frame: within 12 (+/- 2) weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Collaborator
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Medical Affairs study director, sanofi-aventis
  • Overall Official(s)
    • Medical Affairs, Study Director, Sanofi

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