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
  Purpose

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
Peripheral Vascular Diseases

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To determine the sensitivity and specificity of the ECQ versus ABI. [ Time Frame: within 12 (+/- 2) weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2233
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
single group study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076738

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

No publications provided by Sanofi

Additional 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
Study First Received: February 25, 2010
Last Updated: September 10, 2010
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 16, 2014