Prevalence of Peripheral Arterial Disease in Subjects With a Moderate CVD Risk, With No Overt Vascular Diseases nOR diAbetes Mellitus

AstraZeneca1 site in 1 country9,000 target enrollmentMay 2007

ConditionsPeripheral Arterial Disease (PAD)Moderate Risk for Cardiovascular Disease (CVD)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease (PAD)
Sponsor: AstraZeneca
Enrollment: 9000
Locations: 1
Primary Endpoint: Prevalence of lower extremities peripheral arterial disease (PAD), in subjects with a moderate CVD risk, with no overt cardiovascular diseases nor diabetes mellitus
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

July 2008

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

Time Frame: 1 visit

Secondary Outcomes

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)