Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00928629




Registration number
NCT00928629
Ethics application status
Date submitted
23/06/2009
Date registered
26/06/2009
Date last updated
13/11/2009

Titles & IDs
Public title
Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease
Scientific 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.
Secondary ID [1] 0 0
D3560L00089
Universal Trial Number (UTN)
Trial acronym
ACHILLES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Ankle-brachial index (ABI) Screening Test

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.


Treatment: Surgery: Ankle-brachial index (ABI) Screening Test
Patients will undergo an ABI measurement
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
1 visit
Secondary outcome [1] 0 0
Prevalence of cardiovascular risk factors in the target population
Timepoint [1] 0 0
1 visit
Secondary outcome [2] 0 0
Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
Timepoint [2] 0 0
1 visit
Secondary outcome [3] 0 0
Subject characteristics that are determinants of PAD diagnosis
Timepoint [3] 0 0
1 visit

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Edgecliff
Recruitment hospital [2] 0 0
Research Site - Hinchinbrook
Recruitment hospital [3] 0 0
Research Site - Kingsford
Recruitment hospital [4] 0 0
Research Site - Kingswood
Recruitment hospital [5] 0 0
Research Site - Liverpool
Recruitment hospital [6] 0 0
Research Site - Mosman
Recruitment hospital [7] 0 0
Research Site - Neutral Bay
Recruitment hospital [8] 0 0
Research Site - Sydney
Recruitment hospital [9] 0 0
Research Site - Aspley
Recruitment hospital [10] 0 0
Research Site - Morayfield
Recruitment hospital [11] 0 0
Research Site - Parkwood
Recruitment hospital [12] 0 0
Research Site - Beulah Park
Recruitment hospital [13] 0 0
Research Site - Glenelg East
Recruitment hospital [14] 0 0
Research Site - Surrey Downs
Recruitment hospital [15] 0 0
Research Site - Bridgewater
Recruitment hospital [16] 0 0
Research Site - Kingston
Recruitment hospital [17] 0 0
Research Site - Sandy Bay
Recruitment hospital [18] 0 0
Research Site - Brighton
Recruitment hospital [19] 0 0
Research Site - Lalor
Recruitment hospital [20] 0 0
Research Site - Preston
Recruitment hospital [21] 0 0
Research Site - Booragoon
Recruitment hospital [22] 0 0
Research Site - East Victoria Park
Recruitment hospital [23] 0 0
Research Site - Woodvale
Recruitment postcode(s) [1] 0 0
- Edgecliff
Recruitment postcode(s) [2] 0 0
- Hinchinbrook
Recruitment postcode(s) [3] 0 0
- Kingsford
Recruitment postcode(s) [4] 0 0
- Kingswood
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment postcode(s) [6] 0 0
- Mosman
Recruitment postcode(s) [7] 0 0
- Neutral Bay
Recruitment postcode(s) [8] 0 0
- Sydney
Recruitment postcode(s) [9] 0 0
- Aspley
Recruitment postcode(s) [10] 0 0
- Morayfield
Recruitment postcode(s) [11] 0 0
- Parkwood
Recruitment postcode(s) [12] 0 0
- Beulah Park
Recruitment postcode(s) [13] 0 0
- Glenelg East
Recruitment postcode(s) [14] 0 0
- Surrey Downs
Recruitment postcode(s) [15] 0 0
- Bridgewater
Recruitment postcode(s) [16] 0 0
- Kingston
Recruitment postcode(s) [17] 0 0
- Sandy Bay
Recruitment postcode(s) [18] 0 0
- Brighton
Recruitment postcode(s) [19] 0 0
- Lalor
Recruitment postcode(s) [20] 0 0
- Preston
Recruitment postcode(s) [21] 0 0
- Booragoon
Recruitment postcode(s) [22] 0 0
- East Victoria Park
Recruitment postcode(s) [23] 0 0
- Woodvale

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Pretium Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Simon Fisher
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00928629