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

November 11, 2009 updated by: AstraZeneca

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • 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
        • Research Site
    • Queensland
      • Aspley, Queensland, Australia
        • Research Site
      • Morayfield, Queensland, Australia
        • Research Site
      • Parkwood, Queensland, Australia
        • Research Site
    • South Australia
      • Beulah Park, South Australia, Australia
        • Research Site
      • Glenelg East, South Australia, Australia
        • Research Site
      • Surrey Downs, South Australia, Australia
        • Research Site
    • Tasmania
      • Bridgewater, Tasmania, Australia
        • Research Site
      • Kingston, Tasmania, Australia
        • Research Site
      • Sandy Bay, Tasmania, Australia
        • Research Site
    • Victoria
      • Brighton, Victoria, Australia
        • Research Site
      • Lalor, Victoria, Australia
        • Research Site
      • Preston, Victoria, Australia
        • Research Site
    • Western Australia
      • Booragoon, Western Australia, Australia
        • Research Site
      • East Victoria Park, Western Australia, Australia
        • Research Site
      • Woodvale, Western Australia, Australia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: 1 visit
1 visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Prevalence of cardiovascular risk factors in the target population
Time Frame: 1 visit
1 visit
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
Time Frame: 1 visit
1 visit
Subject characteristics that are determinants of PAD diagnosis
Time Frame: 1 visit
1 visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pretium Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Simon Fisher, AstraZeneca
  • Study Director: Amelia Siu, AstraZeneca
  • Principal Investigator: David Sullivan, Central Clinical School, The University of Sydney, Sydney, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3560L00089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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