Peripheral Arterial DiseaseACHILLESNCT00928629
Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease
A study testing Ankle-brachial index (ABI) Screening Test in people with Peripheral Arterial Disease, run by AstraZeneca at 23 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ankle-brachial index (ABI) Screening Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 23 sitesAustralia
- Study dates
- Jun 2009to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Australia23 sites
Research Site
Aspley, Queensland
Research Site
Beulah Park, South Australia
Research Site
Booragoon, Western Australia
Research Site
Bridgewater, Tasmania
Research Site
Brighton, Victoria
Research Site
East Victoria Park, Western Australia
Research Site
Edgecliff, New South Wales
Research Site
Glenelg East, South Australia
Research Site
Hinchinbrook, New South Wales
Research Site
Kingsford, New South Wales
Research Site
Kingston, Tasmania
Research Site
Kingswood, New South Wales
Research Site
Lalor, Victoria
Research Site
Liverpool, New South Wales
Research Site
Morayfield, Queensland
Research Site
Mosman, New South Wales
Research Site
Neutral Bay, New South Wales
Research Site
Parkwood, Queensland
Research Site
Preston, Victoria
Research Site
Sandy Bay, Tasmania
Research Site
Surrey Downs, South Australia
Research Site
Sydney, New South Wales
Research Site
Woodvale, Western Australia
About this study
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.
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Ankle-brachial index (ABI) Screening Test
- Keywords
- Peripheral Arterial Disease, Cardiovascular Disease, Vascular Disease
- Medical subject headings
- Peripheral Arterial Disease, Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-brachial index (ABI) Screening TestProcedure or surgery
Patients will undergo an ABI measurement
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Other | 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. Receives: Procedure: Ankle-brachial index (ABI) Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 visit
Secondary outcomes (3)
Prevalence of cardiovascular risk factors in the target population
Measured: 1 visit
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
Measured: 1 visit
Subject characteristics that are determinants of PAD diagnosis
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pretium Pty Ltd
- Investigators
- Simon Fisher, Study director, AstraZenecaAmelia Siu, Study director, AstraZenecaDavid Sullivan, Principal investigator, Central Clinical School, The University of Sydney, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928629
- Sponsor's protocol ID
- D3560L00089
- Acronym
- ACHILLES
- Status last verified
- Nov 2009
- First submitted
- 23 Jun 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00928629
- Acronym / sponsor ID
- ACHILLES / D3560L00089
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Cardiovascular Disease, Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Pretium Pty Ltd
- Study start
- Jun 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Other | Procedure: Ankle-brachial index (ABI) Screening TestABI Screening Test Population: Subjects of either sex, any race, with at least two of the specified CVD risk factors, with no overt cardiovascular disease. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle-brachial index (ABI) Screening TestPatients will undergo an ABI measurement | Procedure or surgery | All Subjects |
Primary outcome
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
3 secondary outcomes
Prevalence of cardiovascular risk factors in the target population
Time frame: 1 visit
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
Time frame: 1 visit
Subject characteristics that are determinants of PAD diagnosis
Time frame: 1 visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Fisher study director
AstraZeneca
Amelia Siu study director
AstraZeneca
David Sullivan principal investigator
Central Clinical School, The University of Sydney, Sydney, Australia
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle-brachial index (ABI) Screening Test in people with Peripheral Arterial Disease, run by AstraZeneca at 23 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.