Clinical trial NCT04903912: Campania Registry On Peripheral Artery Disease
Official title: Campania Registry On Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease
Keywords: Outcome
Peripheral revascularization
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected di peripheral artery disease

Brief 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.

Eligibility criteria: 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.

Exclusion Criteria:

Refusal to sign the informed consent

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 10 years
measure: Major Adverse Limb Events (MALE)
timeFrame: 10 years
Secondary outcomes:
measure: Any adverse event other than MACE or MALE
timeFrame: 10 years
measure: Bleeding events
timeFrame: 10 years
measure: Instrumental assessment of functional capacity
timeFrame: 10 years
measure: Assessment of quality of life
timeFrame: 10 years
measure: Assessment of functional status
timeFrame: 10 years
measure: Assessment of frailty in geriatric population
timeFrame: 10 years
measure: Assessment of functional status in geriatric population
timeFrame: 10 years
measure: Assessment of cognitive performance in geriatric population
timeFrame: 10 years
measure: Evaluation of lipid profile
timeFrame: 10 years
measure: Evaluation of metabolic profile
timeFrame: 10 years
measure: Atherosclerosis progression
timeFrame: 10 years
measure: P2Y12 Reaction Unit (PRU) at VerifyNow
timeFrame: 28 days
measure: Area under the curve (AUC) at Multiplate with ADP test
timeFrame: 28 days
measure: Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l
timeFrame: 28 days
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Advanced Biomedical Sciences, University of Naples "Federico II"
Study officials:
References:
citation: 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 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). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
citation: 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 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). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.
citation: 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.