Campania Registry On Peripheral Artery Disease (CARE-PAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Diagnostic test: Vascular ultrasound or other imaging methods according to current guidelines; Diagnostic test: Laboratory tests; Drug: Medical treatment according to current guidelines; Procedure: Endovascular od surgical peripheral revascularizations

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Giuseppe Giugliano, MD, PhD; Phone Number: +390817462240; Email: giuseppe.giugliano@unina.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Advanced Biomedical Sciences, University of Naples "Federico II"
    • Contact: Giuseppe Giugliano, MD, PhD; Phone Number: 00390817462240; Email: giuseppe.giugliano@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients affected di peripheral artery disease

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any adverse event other than MACE or MALE	Any-cause death or any adverse cardiovascular event other than MACE or MALE (transient ischemic attack, unstable angina, any coronary, carotid or peripheral revascularization);	10 years
Bleeding events	Periodic assessment of bleeding events according to the BARC classification	10 years
Instrumental assessment of functional capacity	Instrumental assessment of maximum walking distance (MWD) (meters)	10 years
Assessment of quality of life	Quality of life will be periodically assessed by evaluating change in EuroQol (EQ) - 5 Dimensions (5D) - 5 Levels (5L) questionnaire (EQ-5D-5L™) from baseline (range 0-1 with 0 expressing the worst health state and 1 the best)	10 years
Assessment of functional status	Walking capacity will be periodically assessed by evaluating change in Walking Impairment Questionnaire (WIQ) from baseline; range 0-100%, where 0% represents the lowest possible score (ie, answering "unable" for all questions in that category) and 100% represents the highest possible score (ie, indicating "none" with regard to difficulty for all questions in that category)	10 years
Assessment of frailty in geriatric population	All patients aged 65 and over will be assessed for frailty through the Multidimensional Prognostic Index (MPI), a multidimensional score (range 0-1; 0.00-0.33 mild frailty; 0.34-0.66 moderate frailty; 0.67-1.00 severe frailty).	10 years
Assessment of functional status in geriatric population	Functional status for all patients aged 65 and over will be further assessed with Short Physical Performance Battery (SPPB) (pathologic if ≤ 8 in males and ≤ 7 in females) and Handgrip strength (pathologic in men for ≤ 29 kg when BMI ≤ 24 kg/m2 or ≤ 30 kg when BMI 24,1-28 kg/m2 or ≤ 32 kg when BMI > 28 kg/m2; pathologic in women for ≤ 17 kg when BMI ≤ 23 kg/m2 or ≤ 17,3 kg when BMI 23,1-26 kg/m2 or ≤ 18 kg when BMI 26,1-29 kg/m2 or ≤ 21 kg when BMI > 29 kg/m2)	10 years
Assessment of cognitive performance in geriatric population	Cognitive status for all patients aged 65 and over will be assessed with: Mini Mental State Examination (MMSE) (< 24/30 normal; 18-24/30 mild cognitive impairment; 12-18/30 moderate cognitive impairment; <12/30 severe cognitive impairment); Clock Drawing Test (pathologic if ≤ 3/5); Digit span forward (pathologic if ≤ 4/16; borderline if 4-5/16; normal if > 5/16) and backward (pathologic if ≤ 3/16; borderline if 3-4/16; normal if > 4/16); Trail making test A (pathologic if > 78 seconds) and B (pathologic if > 273 seconds); Hospital Anxiety and Depression Scale (HADS) ( 0-7 normal; 8-10 borderline; 11-21 pathologic)	10 years
Evaluation of lipid profile	Periodic evaluation of lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mg/dl)	10 years
Evaluation of metabolic profile	Periodic evaluation of glucose levels (mg/dl)	10 years
Atherosclerosis progression	Periodical ultrasound evaluation of the progression of atherosclerosis at different vascular districts [measurement of degree of stenosis (%)]	10 years
P2Y12 Reaction Unit (PRU) at VerifyNow	Platelet aggregation assessed with VerifyNow ADP test in patients who start dual antiplatelet therapy or dual antithrombotic therapy	28 days
Area under the curve (AUC) at Multiplate with ADP test	Platelet aggregation assessed with Multiplate ADP test in patients who start dual antiplatelet therapy or dual antithrombotic therapy	28 days
Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l	Platelet inhibition assessed with LTA-ADP 20 µmol/l in patients who start dual antiplatelet therapy or dual antithrombotic therapy	28 days

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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. Erratum In: Eur Heart J. 2015 Nov 1;36(41):2779.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2031
• Study Completion (Anticipated): May 1, 2031

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Outcome; Peripheral revascularization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 95/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No