Campania Registry On Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Refusal to sign the informed consent
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 10 years
Death from cardiovascular causes Non-fatal myocardial infarction Non-fatal stroke Ruptured aortic aneurysm
Major Adverse Limb Events (MALE)
时间窗: 10 years
Development of critical limb ischemia Peripheral revascularization for development of severe ischemia Any amputation
次要结局
- Any adverse event other than MACE or MALE(10 years)
- Instrumental assessment of functional capacity(10 years)
- Evaluation of lipid profile(10 years)
- Atherosclerosis progression(10 years)
- Bleeding events(10 years)
- Assessment of frailty in geriatric population(10 years)
- P2Y12 Reaction Unit (PRU) at VerifyNow(28 days)
- Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l(28 days)
- Area under the curve (AUC) at Multiplate with ADP test(28 days)
- Assessment of quality of life(10 years)
- Assessment of functional status(10 years)
- Assessment of functional status in geriatric population(10 years)
- Assessment of cognitive performance in geriatric population(10 years)
- Evaluation of metabolic profile(10 years)
研究者
Giuseppe Giugliano
Professor
Federico II University