Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while \>1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.
National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV). The eligible patients with stable CAD will be called by General Practitioners (GPs). For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months. At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler. At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death.
Study Type
OBSERVATIONAL
Enrollment
713
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
MEDICOOP Genova
Genova, GE, Italy
Cooperativa Medici Milano Centro
Milan, MI, Italy
MEDICOOP S. Agata
Reggio Calabria, RC, Italy
ROMAMED Service
Rome, RM, Italy
To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®
The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value \<=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while \>1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.
Time frame: 1 day
To measure the Blood pressure (mmHg)
Time frame: 1 day
To measure the Heart rate (bpm)
Time frame: 1 day
To measure the Weight (kg)
Time frame: 1 day
To measure the Height (cm)
Time frame: 1 day
To measure the Body mass index (Kg/m2)
Time frame: 1 day
To measure the Ankle Brachial Index (ABI) Value
Time frame: 1 day
Clinical History of Limb peripheral artery revascularization
Time frame: 1 day
Clinical History of Limb or foot amputation for arterial vascular disease
Time frame: 1 day
Clinical History of Clinical presentation of lower extremity disease
Time frame: 1 day
Clinical History of Aortic aneurysm
Time frame: 1 day
Clinical History of Carotid artery stenosis
Time frame: 1 day
Clinical History of Heart Failure
Time frame: 1 day
Clinical History of Atrial Fibrillation or Flutter
Time frame: 1 day
Clinical History of Hypertension
Time frame: 1 day
Clinical History of Dyslipidemia
Time frame: 1 day
Clinical History of Chronic Kidney disease
Time frame: 1 day
Clinical History of Stroke
Time frame: 1 day
Clinical History of Transient ischemic attack
Time frame: 1 day
Clinical History of Bleeding
Time frame: 1 day
Clinical History of cancer
Time frame: 1 day
The dietary habits
The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered
Time frame: 1 day
Physical activity
The Physical activity Questionnaire (BRFSS 2 items) will be administered
Time frame: 1 day
Total cholesterol (mg/dL)
Time frame: 1 day
LDL cholesterol (mg/dL)
Time frame: 1 day
HDL cholesterol (mg/dL)
Time frame: 1 day
Triglycerides (mg/dL)
Time frame: 1 day
Glycemia (mg/dL)
Time frame: 1 day
Glycated hemoglobin (only for patients with diabetes mellitus) (%)
Time frame: 1 day
Creatinine (mg/dL)
Time frame: 1 day
Alanine aminotransferase (ALT) (U/L)
Time frame: 1 day
Aspartate aminotransferase (AST) (U/L)
Time frame: 1 day
Hemoglobin (g/dL)
Time frame: 1 day
Platelet count (x 103μL)
Time frame: 1 day
Hematocrit (%)
Time frame: 1 day
Red blood cells (x10^3 ml)
Time frame: 1 day
White blood cells (x10^3 ml)
Time frame: 1 day
Marital status
Time frame: 1 day
Education Status
Time frame: 1 day
Employment status
Time frame: 1 day
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