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

NCT ID: NCT00928629

Last Updated: 2009-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-10-31

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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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All Subjects

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.

Group Type OTHER

Ankle-brachial index (ABI) Screening Test

Intervention Type PROCEDURE

Patients will undergo an ABI measurement

Interventions

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Ankle-brachial index (ABI) Screening Test

Patients will undergo an ABI measurement

Intervention Type PROCEDURE

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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pretium Pty Ltd

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Simon Fisher

Role: STUDY_DIRECTOR

AstraZeneca

Amelia Siu

Role: STUDY_DIRECTOR

AstraZeneca

David Sullivan

Role: PRINCIPAL_INVESTIGATOR

Central Clinical School, The University of Sydney, Sydney, Australia

Locations

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Research Site

Edgecliff, New South Wales, Australia

Site Status

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Hinchinbrook, New South Wales, Australia

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Kingsford, New South Wales, Australia

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Kingswood, New South Wales, Australia

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Liverpool, New South Wales, Australia

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Mosman, New South Wales, Australia

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Neutral Bay, New South Wales, Australia

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Sydney, New South Wales, Australia

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Aspley, Queensland, Australia

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Morayfield, Queensland, Australia

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Parkwood, Queensland, Australia

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Beulah Park, South Australia, Australia

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Glenelg East, South Australia, Australia

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Surrey Downs, South Australia, Australia

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Bridgewater, Tasmania, Australia

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Kingston, Tasmania, Australia

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Sandy Bay, Tasmania, Australia

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Brighton, Victoria, Australia

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Lalor, Victoria, Australia

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Preston, Victoria, Australia

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Booragoon, Western Australia, Australia

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East Victoria Park, Western Australia, Australia

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Woodvale, Western Australia, Australia

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Countries

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Australia

Other Identifiers

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D3560L00089

Identifier Type: -

Identifier Source: org_study_id

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