Clinical trial NCT01224600: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs
Official title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Carotid Stenosis
Abdominal Aortic Aneurysm
Keywords: lower limbs
Arterial Diseases
Lead sponsor: Institut de l'Atherothrombose
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed PAD \< 1 year symptomatic or asymptomatic without any hystory of previous coronary nor cerebrovascular event

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.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm
timeFrame: evaluation during inclusion visit
Secondary outcomes:
measure: 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
timeFrame: evaluation during inclusion visit
measure: 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
timeFrame: evaluation during inclusion visit
measure: 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
timeFrame: evaluation during inclusion visit
measure: incidence and cardiovascular risk factor
timeFrame: 3 months, 1, 2 and 3 years
measure: incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations
timeFrame: 3 Months, 1, 2 and 3 years
measure: useful of the screening
timeFrame: 3 years
Other outcomes:
Locations:
city: Chênée
country: Belgium
facility: University hospital Liège
city: Abbeville
country: France
facility: Hospital
city: Alençon
country: France
facility: Office-based Specialist in vascular medecine
city: Ambarès et Lagrave
country: France
facility: Office-based Specialist in vascular medecine
city: Amiens
country: France
facility: University Hospital Amiens
city: Amiens
country: France
facility: Office-based Specialist in vascular medecine
city: Annecy
country: France
facility: Office-based Specialist in vascular medecine
city: Armentières
country: France
facility: Hospital center Armentières
city: Arpajon
country: France
facility: Office-based Specialist in vascular medecine
city: Auxerre
country: France
facility: Office-based Specialist in vascular medecine
city: Basse-terre (Guadeloupe)
country: France
facility: Office-based Specialist in vascular medecine
city: Beauvais
country: France
facility: Office-based Specialist in vascular medecine
city: Blagnac
country: France
facility: Office-based Specialist in vascular medecine
city: Bordeaux
country: France
facility: Hospital Saint-André
city: Bordeaux
country: France
facility: Office-based Specialist in vascular medecine
city: Boulogne Sur Mer
country: France
facility: Hospital center
city: Bourg-en-Bresse
country: France
facility: Office-based Specialist in vascular medecine
city: Bourgoin-Jallieu
country: France
facility: Office-based Specialist in vascular medecine
city: Brest
country: France
facility: Office-based Specialist in vascular medecine
city: Brest
country: France
facility: University Hospital Brest
city: Bretigny
country: France
facility: Office-based Specialist in vascular medecine
city: Brive La Gaillarde
country: France
facility: Hospital center
city: Caen
country: France
facility: University Hospital Caen
city: Cannes
country: France
facility: Office-based Specialist in vascular medecine
city: Carcassonne
country: France
facility: Office-based Specialist in vascular medecine
city: Carcassonne
country: France
facility: Hospital Antoine Gayraud
city: Castres
country: France
facility: Office-based Specialist in vascular medecine
city: Ceyrat
country: France
facility: Office-based Specialist in vascular medecine
city: Chalon-sur-Saone
country: France
facility: Office-based Specialist in vascular medecine
city: Chambéry
country: France
facility: Office-based Specialist in vascular medecine
city: Chartres
country: France
facility: Office-based Specialist in vascular medecine
city: Chesnay
country: France
facility: Hospital Center Versailles
city: Cholet
country: France
facility: Office-based Specialist in vascular medecine
city: Clermont-Ferrand
country: France
facility: Office-based Specialist in vascular medecine
city: Cluses
country: France
facility: Office-based Specialist in vascular medecine
city: Cognac
country: France
facility: Office-based Specialist in vascular medecine
city: Compiègne
country: France
facility: Hospital Center Compiègne
city: Crolles
country: France
facility: Office-based Specialist in vascular medecine
city: Denain
country: France
facility: Office-based Specialist in vascular medecine
city: Dijon
country: France
facility: Bocage Hospital
city: Ermont
country: France
facility: Office-based Specialist in vascular medecine
city: EU
country: France
facility: Office-based Specialist in vascular medecine
city: Fecamp
country: France
facility: Office-based Specialist in vascular medecine
city: Foix
country: France
facility: Hospital center Val d'Ariège
city: Fort de France
country: France
facility: Office-based Specialist in vascular medecine
city: Grenoble
country: France
facility: Office-based Specialist in vascular medecine
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Issy les Moulineaux
country: France
facility: Office-based Specialist in vascular medecine
city: La Membrolle
country: France
facility: Office-based Specialist in vascular medecine
city: La Rochelle
country: France
facility: Office-based Specialist in vascular medecine
city: Lens
country: France
facility: Hospital Center Lens
city: Levallois-Perret
country: France
facility: Office-based Specialist in vascular medecine
city: Lille
country: France
facility: University Hospital Lille
city: Limoges
country: France
facility: University Hospital Limoges
city: Limoges
country: France
facility: Office-based Specialist in vascular medecine
city: Lomme
country: France
facility: Office-based Specialist in vascular medecine
city: Lomme
country: France
facility: Hospital Saint Philibert
city: Longwy
country: France
facility: Office-based Specialist in vascular medecine
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Office-based Specialist in vascular medecine
city: Malemort-sur-Correze
country: France
facility: Office-based Specialist in vascular medecine
city: Maubeuge
country: France
facility: Office-based Specialist in vascular medecine
city: Montbéliard
country: France
facility: Hospital of Belfort
city: Montelimar
country: France
facility: Office-based Specialist in vascular medecine
city: Montluçon
country: France
facility: Office-based Specialist in vascular medecine
city: Montpellier
country: France
facility: University hospital Montpellier
city: Mulhouse
country: France
facility: Office-based Specialist in vascular medecine
city: Nice
country: France
facility: Office-based Specialist in vascular medecine
city: Niort
country: France
facility: Office-based Specialist in vascular medecine
city: Noumea
country: France
facility: Office-based Specialist in vascular medecine
city: Orleans
country: France
facility: Office-based Specialist in vascular medecine
city: Orléans
country: France
facility: Hospital Center
city: Papeete
country: France
facility: Hospital center Territorial Mamao
city: Paris
country: France
facility: Office-based Specialist in vascular medecine
city: Peronne
country: France
facility: Office-based Specialist in vascular medecine
city: Perpignan
country: France
facility: Office-based Specialist in vascular medecine
city: Pontcharra
country: France
facility: Office-based Specialist in vascular medecine
city: Pornic
country: France
facility: Office-based Specialist in vascular medecine
city: Puilboreau
country: France
facility: Office-based Specialist in vascular medecine
city: Périgueux
country: France
facility: Hospital Center
city: Rambouillet
country: France
facility: Office-based Specialist in vascular medecine
city: Rochefort
country: France
facility: Office-based Specialist in vascular medecine
city: Rodez
country: France
facility: Office-based Specialist in vascular medecine
city: Rodez
country: France
facility: Hospital center Rodez
city: Rouen
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Aubin de Medoc
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Aubin sur Scie
country: France
facility: Office-based Specialist in vascular medecine
city: Saint benoît
country: France
facility: Office-based Specialist in vascular medecine
city: Saint Etienne
country: France
facility: University Hospital Saint Etienne
city: Saint-Etienne
country: France
facility: Office-based Specialist in vascular medecine
city: Saint-Lo
country: France
facility: Memorial Hospital
city: Saint-Lo
country: France
facility: Office-based Specialist in vascular medecine
city: Saint-Priest
country: France
facility: Office-based Specialist in vascular medecine
city: Saint-Quentin
country: France
facility: Hospital
city: Sallanches
country: France
facility: Office-based Specialist in vascular medecine
city: Sarcelles
country: France
facility: Office-based Specialist in vascular medecine
city: Sarrebourg
country: France
facility: Office-based Specialist in vascular medecine
city: Sarreguemines
country: France
facility: Office-based Specialist in vascular medecine
city: Savigny-sur-Orge
country: France
facility: Office-based Specialist in vascular medecine
city: Selestat
country: France
facility: Office-based Specialist in vascular medecine
city: Strasbourg
country: France
facility: Office-based Specialist in vascular medecine
city: Toulon
country: France
facility: Office-based Specialist in vascular medecine
city: Toulouse
country: France
facility: University Hospital Rangueil
city: Toulouse
country: France
facility: Office-based Specialist in vascular medecine
city: Tours
country: France
facility: Office-based Specialist in vascular medecine
city: Trelaze
country: France
facility: Office-based Specialist in vascular medecine
city: Trois-Rivières (Guadeloupe)
country: France
facility: Office-based Specialist in vascular medecine
city: Vannes
country: France
facility: Office-based Specialist in vascular medecine
city: Versailles
country: France
facility: Office-based Specialist in vascular medecine
city: Vienne
country: France
facility: Office-based Specialist in vascular medecine
city: Villeurbanne
country: France
facility: Office-based Specialist in vascular medecine
city: Vincennes
country: France
facility: Office-based Specialist in vascular medecine
city: Vizille
country: France
facility: Office-based Specialist in vascular medecine
city: Voiron
country: France
facility: Office-based Specialist in vascular medecine
city: Wissembourg
country: France
facility: Office-based Specialist in vascular medecine
Study officials:
affiliation: University Hospital, Grenoble
name: Patrick CARPENTIER, Professor
role: PRINCIPAL_INVESTIGATOR
References: