Campania Registry On Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

— CARE-PAD  

Official title:

Campania Registry On Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903912
• Other study ID #: 95/21
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2031

Study information

• Verified date: May 2021
• Source: Federico II University
• Contact: Giuseppe Giugliano, MD, PhD
• Phone: +390817462240
• Email: giuseppe.giugliano[@]unina.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 1, 2031
• Est. primary completion date: May 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• Vascular ultrasound or other imaging methods according to current guidelines
Peripheral vascular ultrasound / ankle/brachial index / CT angiography / MR angiography / angiography
• Laboratory tests
Metabolic profile and platelet reactivity

Drug:
• Medical treatment according to current guidelines
Antithrombotic drugs, lipid-lowering drugs, antihypertensive drugs, and pharmacotherapy to increase walking capacity according to current guidelines

Procedure:
• Endovascular od surgical peripheral revascularizations
Endovascular od surgical peripheral revascularizations according to current guidelines

Locations

Country	Name	City	State
Italy	Department of Advanced Biomedical Sciences, University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Aboyans V, Ricco JB, Bartelink MEL, Björck 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, Röther 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. — View Citation

Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwöger 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. Erratum in: Eur Heart J. 2015 Nov 1;36(41):2779. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events (MACE)	Death from cardiovascular causes Non-fatal myocardial infarction Non-fatal stroke Ruptured aortic aneurysm	10 years
Primary	Major Adverse Limb Events (MALE)	Development of critical limb ischemia Peripheral revascularization for development of severe ischemia Any amputation	10 years
Secondary	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
Secondary	Bleeding events	Periodic assessment of bleeding events according to the BARC classification	10 years
Secondary	Instrumental assessment of functional capacity	Instrumental assessment of maximum walking distance (MWD) (meters)	10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of lipid profile	Periodic evaluation of lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mg/dl)	10 years
Secondary	Evaluation of metabolic profile	Periodic evaluation of glucose levels (mg/dl)	10 years
Secondary	Atherosclerosis progression	Periodical ultrasound evaluation of the progression of atherosclerosis at different vascular districts [measurement of degree of stenosis (%)]	10 years
Secondary	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
Secondary	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
Secondary	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