Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study.
BACKGROUND
Lower extremity peripheral arterial disease (PAD) is a marker of widespread atherosclerosis. Individuals with PAD, most of whom do not show typical PAD symptoms ('asymptomatic' patients), are at increased risk of cardiovascular ischaemic events. American College of Cardiology/American Heart Association guidelines recommend that individuals with asymptomatic lower extremity PAD should be identified by measurement of ankle-brachial index (ABI). However, despite its associated risk, PAD remains under-recognised by clinicians and the general population and office-based ABI detection is still poorly-known and under-used in clinical practice. The Prevalence of peripheral Arterial disease in patients with a non-high cardiovascular disease risk, with No overt vascular Diseases nOR diAbetes mellitus (PANDORA) study has a primary aim of assessing the prevalence of lower extremity PAD through ABI measurement, in patients at non-high cardiovascular risk, with no overt cardiovascular diseases (including symptomatic PAD), or diabetes mellitus. Secondary objectives include documenting the prevalence and treatment of cardiovascular risk factors and the characteristics of both patients and physicians as possible determinants for PAD under-diagnosis.


METHODS
PANDORA is a non-interventional, cross-sectional, pan-European study. It includes approximately 1,000 primary care participating sites, across six European countries (Belgium, France, Greece, Italy, The Netherlands, Switzerland). Investigator and patient questionnaires will be used to collect both right and left ABI values at rest, presence of cardiovascular disease risk factors, current pharmacological treatment, and determinants for PAD under-diagnosis.


CONCLUSIONS
The PANDORA study will provide important data to estimate the prevalence of asymptomatic PAD in a population otherwise classified at low or intermediate risk on the basis of current risk scores in a primary care setting.


BACKGROUND
Clinical Trials.gov Identifier: NCT00689377.
Cimminiello
Claudio
C
Department of Medicine, via Cesare Battisti 23, Vimercate Hospital, Vimercate (MI), 20059, Italy. claudio.cimminiello@aovimercate.org
Borghi
Claudio
C
Kownator
Serge
S
Wautrecht
Jean Claude
JC
Carvounis
Christos P
CP
Kranendonk
Stefanus E
SE
Kindler
Beat
B
Mangrella
Mario
M
D000572:American Heart Association; D055109:Ankle Brachial Index; D015415:Biomarkers / Q000378:metabolism*; D015340:Epidemiologic Research Design; D005060:Europe; D006801:Humans; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology* / Q000503:physiopathology; D017410:Practice Guidelines as Topic; D015995:Prevalence; D012307:Risk Factors; D011795:Surveys and Questionnaires; D014481:United States
D015415:Biomarkers