Table 1 Study objectives and selection criteria

• To establish the prevalence of lower extremity PAD, defined as an ABI ≤0.9 in patients with at least two cardiovascular disease (CVD) risk factors, with no overt CVDs, including typical symptoms of PAD, or diabetes mellitus

• To establish the prevalence of PAD in the context of the cardiovascular risk level as assessed by the current CVD risk charts or algorithms

• To establish the prevalence of CVD risk factors in patients with at least two CVD risk factors, with no overt CVDs or diabetes mellitus

• To establish the risk factor treatment in patients with at least two CVD risk factors, with no overt CVDs or diabetes mellitus

• To identify determinants (i.e. patient and physician characteristics) for PAD under-diagnosis, defined as the detection of an ABI ≤0.9 in a patient never diagnosed for PAD

Inclusion criteria

Exclusion criteria

• Either sex, any race

• Fewer than two risk factors for CVD

• Males aged ≥45 years or females aged ≥55 years (age-related CVD risk factor)

• Symptoms of PAD

• At least one additional risk factor for CVD, from the following:

• Type 1 or 2 diabetes mellitus

   - cigarette smoking (any amount of tobacco smoked in the past month)

• CHD, including history of myocardial infarction, unstable angina, stable angina, coronary artery procedures (coronary artery bypass graft or percutaneous coronary intervention), or evidence of clinically significant myocardial ischaemia

   - arterial blood hypertension (arterial blood pressure: ≥140 mmHg systolic and/or ≥90 mmHg diastolic or taking antihypertensive medication)

• CHD risk-equivalents, that include clinical manifestations of non-coronary forms of atherosclerotic disease, i.e. abdominal aortic aneurysm, or carotid artery disease (transient ischaemic attack or stroke)

   - low high-density lipoprotein (HDL) cholesterol (<40 mg/dL, corresponding to <1.0 mmol/L) or high LDL cholesterol (≥130 mg/dL, corresponding to ≥3.3 mmol/L), within 3 months of study entry

• No blood lipid data collected in the last 12 months

   - family history of premature coronary heart disease (CHD) before 55 years of age in father or other male first-degree relative, or before 65 years in mother or other female first-degree relative

• Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study

   - elevated waist circumference (≥102 cm for male; ≥88 cm for female)

• Patient who is unwilling or unable to provide informed consent

• Willingness to participate in the study and complying with the study by signing a written informed consent