Screening DIVA - Diffuse Vascular Disease

Sanofi

Status: Completed

Conditions: Peripheral Vascular Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT01076738

DIREG_L_04222

Details and patient eligibility

About

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.

Enrollment: 2,233 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,233 participants in 1 patient group

single group study