Screening DIVA - Diffuse Vascular Disease

Sanofi2,233 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

2,233

Conditions

Peripheral Vascular Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis Administrative Office

Laval, Canada

Outcomes

Primary Outcomes

To determine the sensitivity and specificity of the ECQ versus ABI.

Time frame: within 12 (+/- 2) weeks

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

Data from ClinicalTrials.gov

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