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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Arterial Disease, Carotid Stenosis, Abdominal Aortic Aneurysm

Intervention / Treatment
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* Other: patients with newly diagnosed PAD (<1year)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patient with newly diagnosed PAD (< 1 year) | Other: patients with newly diagnosed PAD (<1year)<br>* 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<br>* Other names: aortic aneurysm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm |  | evaluation during inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 |  | evaluation during inclusion visit | 
| incidence and cardiovascular risk factor |  | 3 months, 1, 2 and 3 years | 
| incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations |  | 3 Months, 1, 2 and 3 years | 
| useful of the screening | decision analysis | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower limbs, Arterial Diseases