Campania Registry On Peripheral Artery Disease

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Major Adverse Cardiovascular Events (MACE) [Срок оценки: 10 years]
• Major Adverse Limb Events (MALE) [Срок оценки: 10 years]

Вторичные конечные точки (12)

• Any adverse event other than MACE or MALE [Срок оценки: 10 years]
• Bleeding events [Срок оценки: 10 years]
• Instrumental assessment of functional capacity [Срок оценки: 10 years]
• Assessment of quality of life [Срок оценки: 10 years]
• Assessment of functional status [Срок оценки: 10 years]
• Assessment of frailty in geriatric population [Срок оценки: 10 years]
• Assessment of functional status in geriatric population [Срок оценки: 10 years]
• Assessment of cognitive performance in geriatric population [Срок оценки: 10 years]
• Evaluation of lipid profile [Срок оценки: 10 years]
• Evaluation of metabolic profile [Срок оценки: 10 years]
• Atherosclerosis progression [Срок оценки: 10 years]
• P2Y12 Reaction Unit (PRU) at VerifyNow [Срок оценки: 28 days]

Критерии участия

Критерии включения

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.

Критерии исключения

Refusal to sign the informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 1 центр

• Department of Advanced Biomedical Sciences, University of Naples "Federico II" — Naples

Публикации

• Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with PMID 28886620
• Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic a PMID 25173340
• Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1. PMID 23915883

Идентификаторы

NCT: NCT04903912 · 95/21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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