Prevalence of Peripheral Arterial Disease in Subject With a Moderate Risk of Cardiovascular (CV) Disease (CVD) in Primary Prevention

Completed

• Conditions: Peripheral Arterial Disease (PAD); Moderate Risk for Cardiovascular Disease (CVD)

• Registration Number: NCT00689377
• Lead Sponsor: AstraZeneca

Brief Summary

Non interventional study aimed to establish the prevalence of lower extremity peripheral arterial disease (PAD), defined as an ankle-brachial index (ABI) not above 0.90 in subjects with a moderate risk of cardiovascular disease, with no overt cardiovascular diseases nor diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

• Male subject aged 45 years or above, or female subject aged 55 years or above (age-related CVD risk factor)
• At least another of the following risk factor for CVD: cigarette smoking, hypertension, low HDL cholesterol or high LDL cholesterol, family history of premature coronary heart disease, elevated waist circumference
• Willingness to participate in the survey and complying with the study by signing a written informed consent

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Exclusion Criteria

• No or 1 risk factor for CVD; symptoms of PAD; diabetes mellitus; coronary heart disease or 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 the subject's safety or successful participation in the study; unwilling or unable to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of lower extremities peripheral arterial disease (PAD), in subjects with a moderate CVD risk, with no overt cardiovascular diseases nor diabetes mellitus	1 visit

Secondary Outcome Measures

Name	Time	Method
Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population	1 visit
Cardiovascular risk level and risk factor treatment in the selected population assessed according to the locally adopted risk charts or algorithms	1 visit
Prevalence of cardiovascular risk factors in subjects with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus	1 visit

Trial Locations

Locations (1)

Research Site; 🇨🇭 Zurich, Switzerland