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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00689377

Acronym

PANDORA

Enrollment

9000

Registered

2008-06-03

Start date

2007-05-31

Completion date

2008-07-31

Last updated

2012-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Risk for Cardiovascular Disease (CVD), Peripheral Arterial Disease (PAD)

Keywords

Peripheral Arterial Disease (PAD), Cardiovascular Disease (CVD), Atherosclerotic cardiovascular disease, Atherosclerosis, Primary CVD prevention

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Prevalence of cardiovascular risk factors in subjects with at least two CVD risk factors, with no overt cardiovascular diseases nor diabetes mellitus	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
Determinants (i.e., subject and physician characteristics) for PAD underdiagnosis in the selected population	1 visit

Countries

Belgium, France, Greece, Italy, Netherlands, Switzerland

Outcome results