search
Back to results

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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Ankle-brachial index (ABI) Screening Test
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Cardiovascular Disease, Vascular Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All Subjects

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Prevalence of cardiovascular risk factors in the target population
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
Subject characteristics that are determinants of PAD diagnosis

Full Information

First Posted
June 23, 2009
Last Updated
November 11, 2009
Sponsor
AstraZeneca
Collaborators
Pretium Pty Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00928629
Brief Title
Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease
Acronym
ACHILLES
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
Pretium Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Arterial Disease, Cardiovascular Disease, Vascular Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All Subjects
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Ankle-brachial index (ABI) Screening Test
Intervention Description
Patients will undergo an ABI measurement
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Prevalence of cardiovascular risk factors in the target population
Time Frame
1 visit
Title
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
Time Frame
1 visit
Title
Subject characteristics that are determinants of PAD diagnosis
Time Frame
1 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Fisher
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amelia Siu
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Sullivan
Organizational Affiliation
Central Clinical School, The University of Sydney, Sydney, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Edgecliff
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Hinchinbrook
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Kingsford
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Kingswood
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Mosman
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Neutral Bay
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Aspley
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Morayfield
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Parkwood
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Beulah Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Glenelg East
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Surrey Downs
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Bridgewater
State/Province
Tasmania
Country
Australia
Facility Name
Research Site
City
Kingston
State/Province
Tasmania
Country
Australia
Facility Name
Research Site
City
Sandy Bay
State/Province
Tasmania
Country
Australia
Facility Name
Research Site
City
Brighton
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Lalor
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Preston
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Booragoon
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
East Victoria Park
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Woodvale
State/Province
Western Australia
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs