Screening DIVA - Diffuse Vascular Disease
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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 |
- To determine the sensitivity and specificity of the ECQ versus ABI. [ Time Frame: within 12 (+/- 2) weeks ] [ Designated as safety issue: No ]
- 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 |
Patients with documented ACS or/and IS / TIA
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 More Information
No publications provided
| 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 Vascular Diseases Ischemic Attack, Transient Peripheral Arterial Disease Acute Coronary Syndrome Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Myocardial Ischemia Heart Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013