Clinical trial NCT03921905: Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Official title: Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: Peripheral Artery Disease
Coronary Artery Disease
General Practice
Ankle-brachial index (ABI)
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2019-04-19
Enrollment: 713
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®
timeFrame: 1 day
Secondary outcomes:
measure: To measure the Blood pressure (mmHg)
timeFrame: 1 day
measure: To measure the Heart rate (bpm)
timeFrame: 1 day
measure: To measure the Weight (kg)
timeFrame: 1 day
measure: To measure the Height (cm)
timeFrame: 1 day
measure: To measure the Body mass index (Kg/m2)
timeFrame: 1 day
measure: To measure the Ankle Brachial Index (ABI) Value
timeFrame: 1 day
measure: Clinical History of Limb peripheral artery revascularization
timeFrame: 1 day
measure: Clinical History of Limb or foot amputation for arterial vascular disease
timeFrame: 1 day
measure: Clinical History of Clinical presentation of lower extremity disease
timeFrame: 1 day
measure: Clinical History of Aortic aneurysm
timeFrame: 1 day
measure: Clinical History of Carotid artery stenosis
timeFrame: 1 day
measure: Clinical History of Heart Failure
timeFrame: 1 day
measure: Clinical History of Atrial Fibrillation or Flutter
timeFrame: 1 day
measure: Clinical History of Hypertension
timeFrame: 1 day
measure: Clinical History of Dyslipidemia
timeFrame: 1 day
measure: Clinical History of Chronic Kidney disease
timeFrame: 1 day
measure: Clinical History of Stroke
timeFrame: 1 day
measure: Clinical History of Transient ischemic attack
timeFrame: 1 day
measure: Clinical History of Bleeding
timeFrame: 1 day
measure: Clinical History of cancer
timeFrame: 1 day
measure: The dietary habits
timeFrame: 1 day
measure: Physical activity
timeFrame: 1 day
measure: Total cholesterol (mg/dL)
timeFrame: 1 day
measure: LDL cholesterol (mg/dL)
timeFrame: 1 day
measure: HDL cholesterol (mg/dL)
timeFrame: 1 day
measure: Triglycerides (mg/dL)
timeFrame: 1 day
measure: Glycemia (mg/dL)
timeFrame: 1 day
measure: Glycated hemoglobin (only for patients with diabetes mellitus) (%)
timeFrame: 1 day
measure: Creatinine (mg/dL)
timeFrame: 1 day
measure: Alanine aminotransferase (ALT) (U/L)
timeFrame: 1 day
measure: Aspartate aminotransferase (AST) (U/L)
timeFrame: 1 day
measure: Hemoglobin (g/dL)
timeFrame: 1 day
measure: Platelet count (x 103μL)
timeFrame: 1 day
measure: Hematocrit (%)
timeFrame: 1 day
measure: Red blood cells (x10^3 ml)
timeFrame: 1 day
measure: White blood cells (x10^3 ml)
timeFrame: 1 day
measure: Marital status
timeFrame: 1 day
measure: Education Status
timeFrame: 1 day
measure: Employment status
timeFrame: 1 day
Other outcomes:
measure: The incidence of Acute coronary syndrome
timeFrame: 12 months
measure: The incidence of Stroke
timeFrame: 12 months
measure: The incidence of Transient ischemic attack
timeFrame: 12 months
measure: The incidence of Heart Failure
timeFrame: 12 months
measure: The incidence of Atrial fibrillation or Flutter
timeFrame: 12 months
measure: The incidence of Coronary artery revascularization
timeFrame: 12 months
measure: The incidence of Hospitalization for worsening of PAD
timeFrame: 12 months
measure: The incidence of Limb peripheral artery revascularization
timeFrame: 12 months
measure: The incidence of Lower limb amputation for arterial vascular disease
timeFrame: 12 months
measure: The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion)
timeFrame: 12 months
Locations:
city: Genova
country: Italy
facility: MEDICOOP Genova
state: GE
city: Milan
country: Italy
facility: Cooperativa Medici Milano Centro
state: MI
city: Reggio Calabria
country: Italy
facility: MEDICOOP S. Agata
state: RC
city: Rome
country: Italy
facility: ROMAMED Service
state: RM
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Marta Baviera, PharmD
role: STUDY_DIRECTOR
References:
citation: Baviera M, Foresta A, Fernandez LO, Torrigiani G, Tettamanti M, Roncaglioni MC, Cimminiello C; PAD, C. A. D. Study Group. Peripheral artery disease in patients with stable coronary artery disease in general practice: results from an Italian nationwide study-PAD & CAD study. Intern Emerg Med. 2025 Jan;20(1):159-169. doi: 10.1007/s11739-024-03771-9. Epub 2024 Sep 30.