Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease

Study Overview
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Brief Summary
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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.

Official Title
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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
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Ankle-brachial index (ABI) Screening Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Subjects<br>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. | Procedure: Ankle-brachial index (ABI) Screening Test<br>* Patients will undergo an ABI measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 1 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cardiovascular risk factors in the target population |  | 1 visit | 
| Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study |  | 1 visit | 
| Subject characteristics that are determinants of PAD diagnosis |  | 1 visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Cardiovascular Disease, Vascular Disease