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

Peripheral Artery Disease Clinical Trial

— PAD&CAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921905
• Other study ID #: IRFMN-7825
• Status: Completed
• Start date: September 25, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: November 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• ABI measurement
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD

Locations

Country	Name	City	State
Italy	MEDICOOP Genova	Genova	GE
Italy	Cooperativa Medici Milano Centro	Milan	MI
Italy	MEDICOOP S. Agata	Reggio Calabria	RC
Italy	ROMAMED Service	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of Acute coronary syndrome		12 months
Other	The incidence of Stroke		12 months
Other	The incidence of Transient ischemic attack		12 months
Other	The incidence of Heart Failure		12 months
Other	The incidence of Atrial fibrillation or Flutter		12 months
Other	The incidence of Coronary artery revascularization		12 months
Other	The incidence of Hospitalization for worsening of PAD		12 months
Other	The incidence of Limb peripheral artery revascularization		12 months
Other	The incidence of Lower limb amputation for arterial vascular disease		12 months
Other	The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion)		12 months
Primary	To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®	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.	1 day
Secondary	To measure the Blood pressure (mmHg)		1 day
Secondary	To measure the Heart rate (bpm)		1 day
Secondary	To measure the Weight (kg)		1 day
Secondary	To measure the Height (cm)		1 day
Secondary	To measure the Body mass index (Kg/m2)		1 day
Secondary	To measure the Ankle Brachial Index (ABI) Value		1 day
Secondary	Clinical History of Limb peripheral artery revascularization		1 day
Secondary	Clinical History of Limb or foot amputation for arterial vascular disease		1 day
Secondary	Clinical History of Clinical presentation of lower extremity disease		1 day
Secondary	Clinical History of Aortic aneurysm		1 day
Secondary	Clinical History of Carotid artery stenosis		1 day
Secondary	Clinical History of Heart Failure		1 day
Secondary	Clinical History of Atrial Fibrillation or Flutter		1 day
Secondary	Clinical History of Hypertension		1 day
Secondary	Clinical History of Dyslipidemia		1 day
Secondary	Clinical History of Chronic Kidney disease		1 day
Secondary	Clinical History of Stroke		1 day
Secondary	Clinical History of Transient ischemic attack		1 day
Secondary	Clinical History of Bleeding		1 day
Secondary	Clinical History of cancer		1 day
Secondary	The dietary habits	The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered	1 day
Secondary	Physical activity	The Physical activity Questionnaire (BRFSS 2 items) will be administered	1 day
Secondary	Total cholesterol (mg/dL)		1 day
Secondary	LDL cholesterol (mg/dL)		1 day
Secondary	HDL cholesterol (mg/dL)		1 day
Secondary	Triglycerides (mg/dL)		1 day
Secondary	Glycemia (mg/dL)		1 day
Secondary	Glycated hemoglobin (only for patients with diabetes mellitus) (%)		1 day
Secondary	Creatinine (mg/dL)		1 day
Secondary	Alanine aminotransferase (ALT) (U/L)		1 day
Secondary	Aspartate aminotransferase (AST) (U/L)		1 day
Secondary	Hemoglobin (g/dL)		1 day
Secondary	Platelet count (x 103µL)		1 day
Secondary	Hematocrit (%)		1 day
Secondary	Red blood cells (x10^3 ml)		1 day
Secondary	White blood cells (x10^3 ml)		1 day
Secondary	Marital status		1 day
Secondary	Education Status		1 day
Secondary	Employment status		1 day