Screening DIVA - Diffuse Vascular Disease

Completed

• Conditions: Peripheral Vascular Diseases

• Registration Number: NCT01076738
• Lead Sponsor: Sanofi

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2233

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9)	within 12 (+/- 2) weeks
To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9)	within 12 (+/- 2) weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada