EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

Institut de l'Atherothrombose1,056 enrolled

Overview

The purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

The EVART study is a prospective epidemiological multicenter cohort study, including patients with newly diagnosed PAD (\< 1 year). Initial data on medical history, caracterisation of the PAD (risk factors, main sites and severity of the atherosclerotic lesions),clinical evaluation of undetected previous CV events, standardized US duplex examination of the abdominal aorta and carotid arteries and treatment (type and duration) are collected by the physician into an electronic medical record. A phone follow up at 3 months, 1, 2 and 3 years is realised by the Centre for Clinical Research of Grenoble. Data on mortality, revascularization, treatments prescribed (type and duration), cancer onset, cardiovascular events, carotid stenosis, abdominal aortic aneurysm are collected. All these serious adverse events are documented and reviewed by an independent critical events committee.

Study Type

OBSERVATIONAL

Enrollment

1,056

Conditions

Peripheral Arterial Disease Carotid Stenosis Abdominal Aortic Aneurysm

Interventions

patients with newly diagnosed PAD (<1year)OTHER

patients with newly diagnosed PAD (\<1year) symptomatic or asymptomatic, without any history of previous coronary nor cerebrovascular event, and with no previous investigation of the aorta and cervical arteries were eligible

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient with newly diagnosed PAD \< 1 year * symptomatic or asymptomatic : ABI\<0.9 at rest, claudicants with ABI\<0.85 after treadmill test, or symptomatic patients (Edimburgh questionnaire or trophic changes) with ABI\>1.30 Exclusion Criteria: * history of previous coronory or cerebrovascular event * previous investigation of the aorta and cervical arteries * prisoners * subjets with no affiliation to the social security system or equivalent

Locations (115)

Outcomes

Primary Outcomes

prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm

Time frame: evaluation during inclusion visit

Secondary Outcomes

clinical forms of aortic aneurysm and carotid stenosis, clinical stage of PAD, ABI level, proximal predominance, age, gender, cardiovascular risk factors will be tested like potential aneurysm or carotid stenosis risk factor

Time frame: evaluation during inclusion visit

frequency of prescription of cardiac consultation,coronarography, stress ECG, stress echo, thallium scan and renal and digestive doppler ultrasound. Frequency of coronary and renal revascularization

Time frame: evaluation during inclusion visit

frequency of drug prescription (beta blocker, statin,antiplatelet,ICE, other hypolipidaemic...) Non-drug prescription : dietetic, tabagism, rehabilitation for walking and structured therapeutic education, dietary management

Time frame: evaluation during inclusion visit

incidence and cardiovascular risk factor

Time frame: 3 months, 1, 2 and 3 years

incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations

Time frame: 3 Months, 1, 2 and 3 years

useful of the screening

decision analysis

Time frame: 3 years

Data from ClinicalTrials.gov

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University hospital Liège

Chênée, Belgium

Hospital

Abbeville, France