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

This study has been completed.
Sponsor:
Collaborator:
Pretium Pty Ltd
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00928629
First received: June 23, 2009
Last updated: November 11, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
 Procedure: Ankle-brachial index (ABI) Screening Test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of cardiovascular risk factors in the target population [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
  • Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
  • Subject characteristics that are determinants of PAD diagnosis [ Time Frame: 1 visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2009
Study Completion Date: October 2009
Arms Assigned Interventions
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.
 Procedure: Ankle-brachial index (ABI) Screening Test
Patients will undergo an ABI measurement

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928629

Locations
Australia, New South Wales
Research Site
Edgecliff, New South Wales, Australia
Research Site
Hinchinbrook, New South Wales, Australia
Research Site
Kingsford, New South Wales, Australia
Research Site
Kingswood, New South Wales, Australia
Research Site
Liverpool, New South Wales, Australia
Research Site
Mosman, New South Wales, Australia
Research Site
Neutral Bay, New South Wales, Australia
Research Site
Sydney, New South Wales, Australia
Australia, Queensland
Research Site
Aspley, Queensland, Australia
Research Site
Morayfield, Queensland, Australia
Research Site
Parkwood, Queensland, Australia
Australia, South Australia
Research Site
Beulah Park, South Australia, Australia
Research Site
Glenelg East, South Australia, Australia
Research Site
Surrey Downs, South Australia, Australia
Australia, Tasmania
Research Site
Bridgewater, Tasmania, Australia
Research Site
Kingston, Tasmania, Australia
Research Site
Sandy Bay, Tasmania, Australia
Australia, Victoria
Research Site
Brighton, Victoria, Australia
Research Site
Lalor, Victoria, Australia
Research Site
Preston, Victoria, Australia
Australia, Western Australia
Research Site
Booragoon, Western Australia, Australia
Research Site
East Victoria Park, Western Australia, Australia
Research Site
Woodvale, Western Australia, Australia
Sponsors and Collaborators
AstraZeneca
Pretium Pty Ltd
Investigators
Study Director: Simon Fisher AstraZeneca
Study Director: Amelia Siu AstraZeneca
Principal Investigator: David Sullivan Central Clinical School, The University of Sydney, Sydney, Australia
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00928629     History of Changes
Other Study ID Numbers: D3560L00089
Study First Received: June 23, 2009
Last Updated: November 11, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by AstraZeneca:
Peripheral Arterial Disease
Cardiovascular Disease
Vascular Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013