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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03921905
Acronym
PAD&CAD
Enrollment
713
Registered
2019-04-19
Start date
2019-09-25
Completion date
2023-11-30
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease, Coronary Artery Disease, General Practice, Ankle-brachial index (ABI)

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTABI measurement

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

Sponsors

Bayer
CollaboratorINDUSTRY
Mario Negri Institute for Pharmacological Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

MeasureTime frameDescription
Hematocrit (%)1 day
Alanine aminotransferase (ALT) (U/L)1 day
Aspartate aminotransferase (AST) (U/L)1 day
Hemoglobin (g/dL)1 day
Platelet count (x 103μL)1 day
Physical activity1 dayThe Physical activity Questionnaire (BRFSS 2 items) will be administered
Red blood cells (x10^3 ml)1 day
White blood cells (x10^3 ml)1 day
Marital status1 day
Education Status1 day
Employment status1 day
To measure the Blood pressure (mmHg)1 day
To measure the Heart rate (bpm)1 day
To measure the Weight (kg)1 day
To measure the Height (cm)1 day
To measure the Body mass index (Kg/m2)1 day
To measure the Ankle Brachial Index (ABI) Value1 day
Clinical History of Limb peripheral artery revascularization1 day
Clinical History of Limb or foot amputation for arterial vascular disease1 day
Clinical History of Clinical presentation of lower extremity disease1 day
Clinical History of Aortic aneurysm1 day
Clinical History of Carotid artery stenosis1 day
Clinical History of Heart Failure1 day
Clinical History of Atrial Fibrillation or Flutter1 day
Clinical History of Hypertension1 day
Clinical History of Dyslipidemia1 day
Clinical History of Chronic Kidney disease1 day
Clinical History of Stroke1 day
Clinical History of Transient ischemic attack1 day
Clinical History of Bleeding1 day
Clinical History of cancer1 day
The dietary habits1 dayThe Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered
Total cholesterol (mg/dL)1 day
LDL cholesterol (mg/dL)1 day
HDL cholesterol (mg/dL)1 day
Triglycerides (mg/dL)1 day
Glycemia (mg/dL)1 day
Glycated hemoglobin (only for patients with diabetes mellitus) (%)1 day
Creatinine (mg/dL)1 day

Other

MeasureTime frame
The incidence of Stroke12 months
The incidence of Transient ischemic attack12 months
The incidence of Heart Failure12 months
The incidence of Atrial fibrillation or Flutter12 months
The incidence of Coronary artery revascularization12 months
The incidence of Hospitalization for worsening of PAD12 months
The incidence of Limb peripheral artery revascularization12 months
The incidence of Lower limb amputation for arterial vascular disease12 months
The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion)12 months
The incidence of Acute coronary syndrome12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026