Screening DIVA - Diffuse Vascular Disease

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01076738
First received: February 25, 2010
Last updated: September 10, 2010
Last verified: September 2010

February 25, 2010
September 10, 2010
April 2009
June 2010   (final data collection date for primary outcome measure)
To determine the sensitivity and specificity of the ECQ versus ABI. [ Time Frame: within 12 (+/- 2) weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076738 on ClinicalTrials.gov Archive Site
  • To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9) [ Time Frame: within 12 (+/- 2) weeks ] [ Designated as safety issue: No ]
  • To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9) [ Time Frame: within 12 (+/- 2) weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with documented ACS or/and IS / TIA

Peripheral Vascular Diseases
Not Provided
single group study
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2233
June 2010
June 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01076738
DIREG_L_04222
Not Provided
Medical Affairs study director, sanofi-aventis
Sanofi
Bristol-Myers Squibb
Study Director: Medical Affairs Sanofi
Sanofi
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP