Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
- Conditions
- Peripheral Artery Disease
- Interventions
- Diagnostic Test: ABI measurement
- Registration Number
- NCT03921905
- Lead Sponsor
- Mario Negri Institute for Pharmacological Research
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 713
- Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.
- Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with CAD ABI measurement In this study will be included patients with stable CAD
- Primary Outcome Measures
Name Time Method To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD® 1 day 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.
- Secondary Outcome Measures
Name Time Method Employment status 1 day Clinical History of Heart Failure 1 day To measure the Body mass index (Kg/m2) 1 day Clinical History of Clinical presentation of lower extremity disease 1 day Clinical History of Transient ischemic attack 1 day Platelet count (x 103μL) 1 day Hematocrit (%) 1 day To measure the Heart rate (bpm) 1 day Clinical History of Limb or foot amputation for arterial vascular disease 1 day Clinical History of Hypertension 1 day The dietary habits 1 day The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered
LDL cholesterol (mg/dL) 1 day HDL cholesterol (mg/dL) 1 day Alanine aminotransferase (ALT) (U/L) 1 day Hemoglobin (g/dL) 1 day Marital status 1 day Education Status 1 day To measure the Blood pressure (mmHg) 1 day To measure the Weight (kg) 1 day To measure the Height (cm) 1 day To measure the Ankle Brachial Index (ABI) Value 1 day Clinical History of Limb peripheral artery revascularization 1 day Clinical History of Aortic aneurysm 1 day Clinical History of Carotid artery stenosis 1 day Clinical History of Atrial Fibrillation or Flutter 1 day Clinical History of Chronic Kidney disease 1 day Clinical History of Bleeding 1 day Physical activity 1 day The Physical activity Questionnaire (BRFSS 2 items) will be administered
Glycated hemoglobin (only for patients with diabetes mellitus) (%) 1 day Clinical History of Dyslipidemia 1 day Clinical History of Stroke 1 day Clinical History of cancer 1 day Total cholesterol (mg/dL) 1 day Glycemia (mg/dL) 1 day Aspartate aminotransferase (AST) (U/L) 1 day Triglycerides (mg/dL) 1 day Creatinine (mg/dL) 1 day Red blood cells (x10^3 ml) 1 day White blood cells (x10^3 ml) 1 day
Trial Locations
- Locations (4)
MEDICOOP Genova
🇮🇹Genova, GE, Italy
ROMAMED Service
🇮🇹Rome, RM, Italy
MEDICOOP S. Agata
🇮🇹Reggio Calabria, RC, Italy
Cooperativa Medici Milano Centro
🇮🇹Milan, MI, Italy