Screening DIVA - Diffuse Vascular Disease

Peripheral Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076738
• Other study ID #: DIREG_L_04222
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: September 10, 2010
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2233
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the sensitivity and specificity of the ECQ versus ABI.		within 12 (+/- 2) weeks	No
Secondary	To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9)		within 12 (+/- 2) weeks	No
Secondary	To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9)		within 12 (+/- 2) weeks	No