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Completed

NCT Number: NCT03921905

Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.

Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

MEDICOOP Genova, Genova, GE, Italy

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About this study

National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV).

The eligible patients with stable CAD will be called by General Practitioners (GPs).

For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months.

At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler.

At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.

Exclusion criteria

  • Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.

Treatment and study plan

ABI measurement

Diagnostic Test

ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD

Primary outcomes

  1. To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®

    Time frame: 1 day

    The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value <=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.

Secondary outcomes

  1. To measure the Blood pressure (mmHg)

    Time frame: 1 day

  2. To measure the Heart rate (bpm)

    Time frame: 1 day

  3. To measure the Weight (kg)

    Time frame: 1 day

  4. To measure the Height (cm)

    Time frame: 1 day

  5. To measure the Body mass index (Kg/m2)

    Time frame: 1 day

  6. To measure the Ankle Brachial Index (ABI) Value

    Time frame: 1 day

  7. Clinical History of Limb peripheral artery revascularization

    Time frame: 1 day

  8. Clinical History of Limb or foot amputation for arterial vascular disease

    Time frame: 1 day

  9. Clinical History of Clinical presentation of lower extremity disease

    Time frame: 1 day

  10. Clinical History of Aortic aneurysm

    Time frame: 1 day

  11. Clinical History of Carotid artery stenosis

    Time frame: 1 day

  12. Clinical History of Heart Failure

    Time frame: 1 day

  13. Clinical History of Atrial Fibrillation or Flutter

    Time frame: 1 day

  14. Clinical History of Hypertension

    Time frame: 1 day

  15. Clinical History of Dyslipidemia

    Time frame: 1 day

  16. Clinical History of Chronic Kidney disease

    Time frame: 1 day

  17. Clinical History of Stroke

    Time frame: 1 day

  18. Clinical History of Transient ischemic attack

    Time frame: 1 day

  19. Clinical History of Bleeding

    Time frame: 1 day

  20. Clinical History of cancer

    Time frame: 1 day

  21. The dietary habits

    Time frame: 1 day

    The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered

  22. Physical activity

    Time frame: 1 day

    The Physical activity Questionnaire (BRFSS 2 items) will be administered

  23. Total cholesterol (mg/dL)

    Time frame: 1 day

  24. LDL cholesterol (mg/dL)

    Time frame: 1 day

  25. HDL cholesterol (mg/dL)

    Time frame: 1 day

  26. Triglycerides (mg/dL)

    Time frame: 1 day

  27. Glycemia (mg/dL)

    Time frame: 1 day

  28. Glycated hemoglobin (only for patients with diabetes mellitus) (%)

    Time frame: 1 day

  29. Creatinine (mg/dL)

    Time frame: 1 day

  30. Alanine aminotransferase (ALT) (U/L)

    Time frame: 1 day

  31. Aspartate aminotransferase (AST) (U/L)

    Time frame: 1 day

  32. Hemoglobin (g/dL)

    Time frame: 1 day

  33. Platelet count (x 103μL)

    Time frame: 1 day

  34. Hematocrit (%)

    Time frame: 1 day

  35. Red blood cells (x10^3 ml)

    Time frame: 1 day

  36. White blood cells (x10^3 ml)

    Time frame: 1 day

  37. Marital status

    Time frame: 1 day

  38. Education Status

    Time frame: 1 day

  39. Employment status

    Time frame: 1 day

Other outcomes

  1. The incidence of Acute coronary syndrome

    Time frame: 12 months

  2. The incidence of Stroke

    Time frame: 12 months

  3. The incidence of Transient ischemic attack

    Time frame: 12 months

  4. The incidence of Heart Failure

    Time frame: 12 months

  5. The incidence of Atrial fibrillation or Flutter

    Time frame: 12 months

  6. The incidence of Coronary artery revascularization

    Time frame: 12 months

  7. The incidence of Hospitalization for worsening of PAD

    Time frame: 12 months

  8. The incidence of Limb peripheral artery revascularization

    Time frame: 12 months

  9. The incidence of Lower limb amputation for arterial vascular disease

    Time frame: 12 months

  10. The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Collaborators

  • Bayer

Registry information

Acronym: PAD&CAD

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 19, 2019
Registry last updated
Dec 3, 2024

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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