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

NCT00928629 | Completed

• 1 other identifier: D3560L00089
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 23

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Cardiovascular Disease; Vascular Disease

Outcome Measures

Primary Outcomes (1)

• 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

  1 visit

Secondary Outcomes (3)

• Prevalence of cardiovascular risk factors in the target population

  1 visit

• Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study

  1 visit

• Subject characteristics that are determinants of PAD diagnosis

  1 visit

Study Arms (1)

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.

Procedure: Ankle-brachial index (ABI) Screening Test

Interventions

Ankle-brachial index (ABI) Screening Test PROCEDURE

Patients will undergo an ABI measurement

All Subjects

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Pretium Pty Ltd: collaborator

Study Sites (23)

Research Site

Edgecliff, New South Wales, Australia

Location

Research Site

Hinchinbrook, New South Wales, Australia

Location

Research Site

Kingsford, New South Wales, Australia

Location

Research Site

Kingswood, New South Wales, Australia

Location

Research Site

Liverpool, New South Wales, Australia

Location

Research Site

Mosman, New South Wales, Australia

Location

Research Site

Neutral Bay, New South Wales, Australia

Location

Research Site

Sydney, New South Wales, Australia

Location

Research Site

Aspley, Queensland, Australia

Location

Research Site

Morayfield, Queensland, Australia

Location

Research Site

Parkwood, Queensland, Australia

Location

Research Site

Beulah Park, South Australia, Australia

Location

Research Site

Glenelg East, South Australia, Australia

Location

Research Site

Surrey Downs, South Australia, Australia

Location

Research Site

Bridgewater, Tasmania, Australia

Location

Research Site

Kingston, Tasmania, Australia

Location

Research Site

Sandy Bay, Tasmania, Australia

Location

Research Site

Brighton, Victoria, Australia

Location

Research Site

Lalor, Victoria, Australia

Location

Research Site

Preston, Victoria, Australia

Location

Research Site

Booragoon, Western Australia, Australia

Location

Research Site

East Victoria Park, Western Australia, Australia

Location

Research Site

Woodvale, Western Australia, Australia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases; Vascular Diseases

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Simon Fisher

  AstraZeneca

  STUDY DIRECTOR

• Amelia Siu

  AstraZeneca

  STUDY DIRECTOR

• David Sullivan

  Central Clinical School, The University of Sydney, Sydney, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

AU (23)