Clinical trial NCT00928629: Audit and Screening Study to Determine the Prevalence of Peripheral Arterial Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Cardiovascular Disease
Vascular Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Pretium Pty Ltd
First posted: 2009-06-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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.

Primary outcomes:
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
timeFrame: 1 visit
Secondary outcomes:
measure: Prevalence of cardiovascular risk factors in the target population
timeFrame: 1 visit
measure: Cardiovascular risk level and cardiovascular risk factor management in the target population pre and post study
timeFrame: 1 visit
measure: Subject characteristics that are determinants of PAD diagnosis
timeFrame: 1 visit
Other outcomes:
Locations:
city: Edgecliff
country: Australia
facility: Research Site
state: New South Wales
city: Hinchinbrook
country: Australia
facility: Research Site
state: New South Wales
city: Kingsford
country: Australia
facility: Research Site
state: New South Wales
city: Kingswood
country: Australia
facility: Research Site
state: New South Wales
city: Liverpool
country: Australia
facility: Research Site
state: New South Wales
city: Mosman
country: Australia
facility: Research Site
state: New South Wales
city: Neutral Bay
country: Australia
facility: Research Site
state: New South Wales
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Aspley
country: Australia
facility: Research Site
state: Queensland
city: Morayfield
country: Australia
facility: Research Site
state: Queensland
city: Parkwood
country: Australia
facility: Research Site
state: Queensland
city: Beulah Park
country: Australia
facility: Research Site
state: South Australia
city: Glenelg East
country: Australia
facility: Research Site
state: South Australia
city: Surrey Downs
country: Australia
facility: Research Site
state: South Australia
city: Bridgewater
country: Australia
facility: Research Site
state: Tasmania
city: Kingston
country: Australia
facility: Research Site
state: Tasmania
city: Sandy Bay
country: Australia
facility: Research Site
state: Tasmania
city: Brighton
country: Australia
facility: Research Site
state: Victoria
city: Lalor
country: Australia
facility: Research Site
state: Victoria
city: Preston
country: Australia
facility: Research Site
state: Victoria
city: Booragoon
country: Australia
facility: Research Site
state: Western Australia
city: East Victoria Park
country: Australia
facility: Research Site
state: Western Australia
city: Woodvale
country: Australia
facility: Research Site
state: Western Australia
Study officials:
affiliation: AstraZeneca
name: Simon Fisher
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Amelia Siu
role: STUDY_DIRECTOR
affiliation: Central Clinical School, The University of Sydney, Sydney, Australia
name: David Sullivan
role: PRINCIPAL_INVESTIGATOR
References: