Screening DIVA - Diffuse Vascular Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01076738

Enrollment

2233

Registered

2010-02-26

Start date

2009-04-30

Completion date

2010-06-30

Last updated

2010-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results