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NCT Number: NCT04903912

Campania Registry On Peripheral Artery Disease

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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Naples, 80131, Italy

Location status: Recruiting

Location contact

Giuseppe Giugliano, MD, PhD

CONTACT

[email protected]

00390817462240

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: 10 years

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

  2. Major Adverse Limb Events (MALE)

    Time frame: 10 years

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

Secondary outcomes

  1. Any adverse event other than MACE or MALE

    Time frame: 10 years

    Any-cause death or any adverse cardiovascular event other than MACE or MALE (transient ischemic attack, unstable angina, any coronary, carotid or peripheral revascularization);

  2. Bleeding events

    Time frame: 10 years

    Periodic assessment of bleeding events according to the BARC classification

  3. Instrumental assessment of functional capacity

    Time frame: 10 years

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

  4. Assessment of quality of life

    Time frame: 10 years

    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)

  5. Assessment of functional status

    Time frame: 10 years

    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)

  6. Assessment of frailty in geriatric population

    Time frame: 10 years

    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).

  7. Assessment of functional status in geriatric population

    Time frame: 10 years

    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)

  8. Assessment of cognitive performance in geriatric population

    Time frame: 10 years

    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)

  9. Evaluation of lipid profile

    Time frame: 10 years

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

  10. Evaluation of metabolic profile

    Time frame: 10 years

    Periodic evaluation of glucose levels (mg/dl)

  11. Atherosclerosis progression

    Time frame: 10 years

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

  12. P2Y12 Reaction Unit (PRU) at VerifyNow

    Time frame: 28 days

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

  13. Area under the curve (AUC) at Multiplate with ADP test

    Time frame: 28 days

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

  14. Inhibition of platelet activity (IPA, %) with LTA-ADP 20 µmol/l

    Time frame: 28 days

    Platelet inhibition assessed with LTA-ADP 20 µmol/l in patients who start dual antiplatelet therapy or dual antithrombotic therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Giugliano, MD, PhD

CONTACT

[email protected]

+390817462240

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Acronym: CARE-PAD

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
May 27, 2021
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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