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Peripheral Artery DiseaseCARE-PADNCT04903912

Campania Registry On Peripheral Artery Disease

An observational study of Peripheral Artery Disease, run by Federico II University at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Vascular ultrasound or other imaging methods according to current guidelines, Laboratory tests and Medical treatment according to current guidelines
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
1 siteItaly
Study dates
1 May 2021to 1 May 2031
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients affected di peripheral artery disease

Who may be able to join

  • 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.

Who cannot join

  • Refusal to sign the informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giuseppe Giugliano, MD, PhD contact

+390817462240

giuseppe.giugliano@unina.it

Italy1 site, 1 recruiting

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

    Naples, 80131

    Giuseppe Giugliano, MD, PhD, 00390817462240, giuseppe.giugliano@unina.it

    Recruiting

Other trials in Italy

About this study

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.

Read the 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.

Being tested
Vascular ultrasound or other imaging methods according to current guidelines, Laboratory tests, Medical treatment according to current guidelines, Endovascular od surgical peripheral revascularizations
Keywords
Outcome, Peripheral revascularization
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vascular ultrasound or other imaging methods according to current guidelinesDiagnostic test

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

  • Laboratory testsDiagnostic test

    Metabolic profile and platelet reactivity

  • Medical treatment according to current guidelinesDrug

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

  • Endovascular od surgical peripheral revascularizationsProcedure or surgery

    Endovascular od surgical peripheral revascularizations according to current guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiovascular Events (MACE)

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

    Measured: 10 years

  2. Major Adverse Limb Events (MALE)

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

    Measured: 10 years

Secondary outcomes (14)

  1. 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);

    Measured: 10 years

  2. Bleeding events

    Periodic assessment of bleeding events according to the BARC classification

    Measured: 10 years

  3. Instrumental assessment of functional capacity

    Instrumental assessment of maximum walking distance (MWD) (meters)

    Measured: 10 years

  4. 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)

    Measured: 10 years

  5. 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)

    Measured: 10 years

  6. 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).

    Measured: 10 years

  7. 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)

    Measured: 10 years

  8. 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)

    Measured: 10 years

  9. Evaluation of lipid profile

    Periodic evaluation of lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mg/dl)

    Measured: 10 years

  10. Evaluation of metabolic profile

    Periodic evaluation of glucose levels (mg/dl)

    Measured: 10 years

  11. Atherosclerosis progression

    Periodical ultrasound evaluation of the progression of atherosclerosis at different vascular districts [measurement of degree of stenosis (%)]

    Measured: 10 years

  12. P2Y12 Reaction Unit (PRU) at VerifyNow

    Platelet aggregation assessed with VerifyNow ADP test in patients who start dual antiplatelet therapy or dual antithrombotic therapy

    Measured: 28 days

  13. 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

    Measured: 28 days

  14. 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

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start1 May 2021
  3. Primary completion1 May 2031 (estimated)
  4. Study completion1 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903912
Sponsor's protocol ID
95/21
Acronym
CARE-PAD
Status last verified
May 2021
First submitted
21 Apr 2021
Last updated
27 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28886620

  • 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.

    PubMed 25173340

  • 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.

    PubMed 23915883

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Artery Disease, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Giugliano, MD, PhD (+390817462240, giuseppe.giugliano@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiovascular Events (MACE) (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04903912, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.

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Campania Registry On Peripheral Artery Disease | AzTrials