Screening DIVA - Diffuse Vascular Disease

NCT01076738 | Completed

• 1 other identifier: DIREG_L_04222
• Study Type: observational
• Target: 2,233
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

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

  within 12 (+/- 2) weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

single group study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with documented ACS or/and IS / TIA

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Related Publications (1)

• Bell AD, Roussin A, Popovici-Toma D, Girard M, Chiu JF, Huckell V. The value of routine screening for peripheral arterial disease in stable outpatients with a history of coronary artery or cerebrovascular disease. Int J Clin Pract. 2013 Oct;67(10):996-1004. doi: 10.1111/ijcp.12148. Epub 2013 May 21.

  PMID: 23692499 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medical Affairs

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 13, 2010

Record last verified: 2010-09

Locations

CA (1)