NCT04903912

Campania Registry On Peripheral Artery Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The CAmpania REgistry on Peripheral Artery Disease (CARE-PAD) is a single-center observational study which has the purpose to collect clinical, laboratory, instrumental, procedural and follow-up data and to evaluate the outcome of peripheral artery disease (PAD) patients.

Detailed description

PAD patients had widespread atherosclerosis and show a worse prognosis than patients with coronary artery disease alone. The CAmpania REgistry on Peripheral Artery Disease (CARE-PAD) is a single center observational study conducted at the Department of Advanced Biomedical Sciences of the Federico II University of Naples which aims to collect clinical, laboratory, instrumental, procedural and follow-up data and to evaluate short, medium and long term outcome of PAD patients. Patients with established diagnosis of peripheral arterial disease according to current international guidelines will be included in the observational study. The overall duration of the study will be 10 years. The presence of PAD will be confirmed based on clinical and instrumental criteria: * Intermittent claudication and/or critical limb ischemia with presence of haemodynamically significant stenosis/occlusion of the lower limb arteries detected by ultrasound and/or other imaging methods or with ankle/brachial index (ABI) ≤ 0.90. * Carotid stenosis of at least 50% at ultrasound and/or at other imaging methods * Abdominal aortic aneurysm (≥3 cm) found at ultrasound and/or other imaging methods. * History of peripheral/carotid revascularization or of aortic aneurysm treatment. All patients will be managed according to current guidelines and will receive maximal antiatherosclerotic medical therapy to improve cardiovascular prognosis and, if clinically indicated, could undergo peripheral revascularization procedures to improve symptoms and/or limb prognosis. The choice of the revascularization procedure will be based on careful individual evaluation and will take into account, in accordance with current guidelines, several variables such as clinical characteristics, comorbidities, individual surgical risk and feasibility of the percutaneous peripheral revascularization procedure.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Vascular ultrasound or other imaging methods according to current guidelines	Peripheral vascular ultrasound / ankle/brachial index / CT angiography / MR angiography / angiography
DIAGNOSTIC_TEST	Laboratory tests	Metabolic profile and platelet reactivity
DRUG	Medical treatment according to current guidelines	Antithrombotic drugs, lipid-lowering drugs, antihypertensive drugs, and pharmacotherapy to increase walking capacity according to current guidelines
PROCEDURE	Endovascular od surgical peripheral revascularizations	Endovascular od surgical peripheral revascularizations according to current guidelines

Timeline

• Start date: 2021-05-01
• Primary completion: 2031-05-01
• Completion: 2031-05-01
• First posted: 2021-05-27
• Last updated: 2021-05-27

Locations

1 site across 1 country: Italy