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Screening DIVA - Diffuse Vascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01076738
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : September 13, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi

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.


Condition or disease
Peripheral Vascular Diseases

Study Type : Observational
Estimated Enrollment : 2233 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
single group study



Primary Outcome Measures :
  1. To determine the sensitivity and specificity of the ECQ versus ABI. [ Time Frame: within 12 (+/- 2) weeks ]

Secondary Outcome Measures :
  1. To determine the prevalence of symptomatic PAD (positive ECQ and ABIT <0.9) [ Time Frame: within 12 (+/- 2) weeks ]
  2. To determine the prevalence of asymptomatic PAD (negative ECQ and ABI <0.9) [ Time Frame: within 12 (+/- 2) weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with documented ACS or/and IS / TIA
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076738


Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Medical Affairs Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01076738     History of Changes
Other Study ID Numbers: DIREG_L_04222
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases