Campania Registry On Peripheral Artery Disease

NCT04903912 | Recruiting DMC

• 1 other identifier: 95/21
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

Outcome; Peripheral revascularization

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiovascular Events (MACE)

  Death from cardiovascular causes Non-fatal myocardial infarction Non-fatal stroke Ruptured aortic aneurysm

  10 years

• Major Adverse Limb Events (MALE)

  Development of critical limb ischemia Peripheral revascularization for development of severe ischemia Any amputation

  10 years

Secondary Outcomes (14)

• Any adverse event other than MACE or MALE

  10 years

• Bleeding events

  10 years

• Instrumental assessment of functional capacity

  10 years

• Assessment of quality of life

  10 years

• Assessment of functional status

  10 years

Interventions

Vascular ultrasound or other imaging methods according to current guidelines DIAGNOSTIC_TEST

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

Laboratory tests DIAGNOSTIC_TEST

Metabolic profile and platelet reactivity

Medical treatment according to current guidelines DRUG

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

Endovascular od surgical peripheral revascularizations PROCEDURE

Endovascular od surgical peripheral revascularizations according to current guidelines

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected di peripheral artery disease

You may qualify if:

• 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.

You may not qualify if:

• Refusal to sign the informed consent

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

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

Naples, 80131, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 28886620 BACKGROUND

• 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.

  PMID: 25173340 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Giuseppe Giugliano, MD, PhD

CONTACT

+390817462240; giuseppe.giugliano@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 27, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

IT (1)