Led by Federico II University · Updated on 2021-05-27
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What this Trial Is About
Researchers are studying patients with peripheral artery disease (PAD), a condition involving widespread atherosclerosis that often leads to worse outcomes than coronary artery disease alone. This observational study, conducted at Federico II University of Naples, aims to collect detailed clinical, laboratory, imaging, procedural, and follow-up data over 10 years to evaluate the short, medium, and long-term outcomes of PAD patients.
Participants with confirmed PAD based on clinical symptoms and imaging criteria will be included. The study involves monitoring patients who receive medical treatment following current guidelines, including antiatherosclerotic medications and, if needed, peripheral revascularization procedures tailored to individual clinical situations. Diagnostic tests such as vascular ultrasound, ankle/brachial index, CT or MR angiography will be used to assess vascular status.
During the study, participants will undergo regular clinical evaluations, laboratory tests to assess metabolic and platelet reactivity profiles, and instrumental assessments of functional capacity. Researchers will track major adverse cardiovascular and limb events over 10 years, as well as quality of life, frailty, cognitive performance, and atherosclerosis progression. The study also includes a 28-day assessment of platelet activity. This long-term observation will help understand PAD progression and outcomes under standard care.
CONDITIONS
Brief Title
Campania Registry On Peripheral Artery Disease
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
Confirmed diagnosis of peripheral artery disease as one or more of the following: intermittent claudication with significant stenosis/occlusion or ankle/brachial index ≤ 0.90
Critical limb ischemia with significant stenosis/occlusion or ankle/brachial index ≤ 0.90
Presence of carotid stenosis of at least 50%
Presence of abdominal aortic aneurysm ≥ 3 cm
History of peripheral or carotid revascularization or aortic aneurysm treatment
You will not qualify if you...
Refusal to sign the informed consent
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Initial assessment period
Participants undergo vascular ultrasound, ankle/brachial index measurement, and other imaging methods to assess peripheral artery disease according to current guidelines.
1 to 2 visits depending on diagnostic needs
Monitoring
Duration - Up to 10 years
Participants who undergo routine care are observed with periodic laboratory tests and clinical assessments to evaluate cardiovascular and limb outcomes over time.
Regular follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
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Department of Advanced Biomedical Sciences, University of Naples "Federico II"
2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS).
Victor Aboyans, Jean-Baptiste Ricco, Marie-Louise E L Bartelink...
2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC).
Raimund Erbel, Victor Aboyans, Catherine Boileau...
