Campania Registry On Peripheral Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2031-05-01

Brief Summary

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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.

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Detailed Description

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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

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Peripheral Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Vascular ultrasound or other imaging methods according to current guidelines

Peripheral vascular ultrasound / ankle/brachial index / CT angiography / MR angiography / angiography

Intervention Type DIAGNOSTIC_TEST

Laboratory tests

Metabolic profile and platelet reactivity

Intervention Type DIAGNOSTIC_TEST

Medical treatment according to current guidelines

Antithrombotic drugs, lipid-lowering drugs, antihypertensive drugs, and pharmacotherapy to increase walking capacity according to current guidelines

Intervention Type DRUG

Endovascular od surgical peripheral revascularizations

Endovascular od surgical peripheral revascularizations according to current guidelines

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Confirmed diagnosis of peripheral artery disease as follows (one or more of the following):

* Intermittent claudication with presence of hemodynamically significant stenosis/occlusion of lower limb arteries or pathological ABI (≤ 0.90);
* Critical limb ischemia with presence of hemodynamically significant stenosis/occlusion of lower limb arteries or pathological ABI (≤ 0.90);
* Presence of carotid stenosis of at least 50%;
* Presence abdominal aortic aneurysm (≥ 3 cm);
* History of peripheral/carotid revascularization or of aortic aneurysm treatment.