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

Completed

• Conditions: Peripheral Arterial Disease; Carotid Stenosis; Abdominal Aortic Aneurysm
• Interventions: Other: patients with newly diagnosed PAD (<1year)

• Registration Number: NCT01224600
• Lead Sponsor: Institut de l'Atherothrombose

Brief Summary

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

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2011-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1056

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	patients with newly diagnosed PAD (<1year)	patient with newly diagnosed PAD (\< 1 year)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	3 years	decision analysis

Trial Locations

Locations (28)

University hospital Liège; 🇧🇪 Chênée, Belgium

Hospital; 🇫🇷 Saint-Quentin, France

Office-based Specialist in vascular medecine; 🇫🇷 Wissembourg, France

University Hospital Amiens; 🇫🇷 Amiens, France

Hospital center Armentières; 🇫🇷 Armentières, France

Hospital Saint-André; 🇫🇷 Bordeaux, France

University Hospital Caen; 🇫🇷 Caen, France

Hospital Antoine Gayraud; 🇫🇷 Carcassonne, France

Hospital center; 🇫🇷 Brive La Gaillarde, France

University Hospital Brest; 🇫🇷 Brest, France

Hospital Center Versailles; 🇫🇷 Chesnay, France

Hospital Center Lens; 🇫🇷 Lens, France

Hospital Center Compiègne; 🇫🇷 Compiègne, France

Bocage Hospital; 🇫🇷 Dijon, France

Hospital center Val d'Ariège; 🇫🇷 Foix, France

University Hospital Grenoble; 🇫🇷 Grenoble, France

University Hospital Lille; 🇫🇷 Lille, France

University Hospital Limoges; 🇫🇷 Limoges, France

Hospital Saint Philibert; 🇫🇷 Lomme, France

Hospital of Belfort; 🇫🇷 Montbéliard, France

Edouard Herriot Hospital; 🇫🇷 Lyon, France

Hospital Center; 🇫🇷 Périgueux, France

University Hospital Rangueil; 🇫🇷 Toulouse, France

Memorial Hospital; 🇫🇷 Saint-Lo, France

University Hospital Saint Etienne; 🇫🇷 Saint Etienne, France

University hospital Montpellier; 🇫🇷 Montpellier, France

Hospital center Territorial Mamao; 🇫🇷 Papeete, France

Hospital center Rodez; 🇫🇷 Rodez, France