NCT00928629CompletedNot Applicable
Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease. A Cross-sectional Multi-centre Clinical Study in Subjects With Cardiovascular Disease Risk Factors.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,000
- Locations
- 23
- Primary Endpoint
- Prevalence of lower extremity peripheral arterial disease, defined as an ankle-brachial index of < or = 0.9 in subjects with at least two of the specified CVD risk factors, with no overt cardiovascular disease
Study Overview
Brief Summary
The primary objective of the study is to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index of less than or equal to 0.9, in subjects with at least two of the specified cardiovascular disease (CVD) risk factors, with no overt cardiovascular disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males aged 45 years or above or females aged 55 years or above (age related CVD risk factor).
- •At least two other risk factors for CVD: cigarette smoking, diabetes mellitus, hypertension, low HDL or high LDL cholesterol, strong family history of coronary heart disease, elevated waist circumference, Aboriginal and/or Torres Strait Islander.
- •Willingness to participate in study and sufficient command of the English language to read and complete study questionnaire.
Exclusion Criteria
- •Less than 2 risk factors for CVD (other than age), symptoms of PAD, coronary heart disease or coronary heart disease risk equivalents
- •No lipid data collected in the last 12 months
- •Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise safety or successful participation in the study.
Arms & Interventions
All Subjects
Other
ABI Screening Test Population: Subjects of either sex, any race, with at least two of the specified CVD risk factors, with no overt cardiovascular disease.
Intervention: Ankle-brachial index (ABI) Screening Test (Procedure)
Outcomes
Primary Outcomes
Prevalence of lower extremity peripheral arterial disease, defined as an ankle-brachial index of < or = 0.9 in subjects with at least two of the specified CVD risk factors, with no overt cardiovascular disease
Time Frame: 1 visit
Secondary Outcomes
- Prevalence of cardiovascular risk factors in the target population(1 visit)
- Subject characteristics that are determinants of PAD diagnosis(1 visit)
- Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study(1 visit)
Investigators
Study Sites (23)
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