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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: Ankle-brachial index (ABI) Screening Test

• Registration Number: NCT00928629
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-11
• Last Update Posted: 2009-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	Ankle-brachial index (ABI) Screening Test	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇦🇺 Woodvale, Western Australia, Australia