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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