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

Peripheral Arterial Disease Clinical Trial

— EVART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224600
• Other study ID #: DCIC 0704
• Status: Completed
• Phase: N/A
• First received: September 15, 2010
• Last updated: March 5, 2015
• Start date: January 2008
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Institut de l'Atherothrombose
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1056
• Est. completion date: March 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Carotid Stenosis
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• patients with newly diagnosed PAD (<1year)
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

Locations

Country	Name	City	State
Belgium	University hospital Liège	Chênée
France	Hospital	Abbeville
France	Office-based Specialist in vascular medecine	Alençon
France	Office-based Specialist in vascular medecine	Ambarès et Lagrave
France	Office-based Specialist in vascular medecine	Amiens
France	University Hospital Amiens	Amiens
France	Office-based Specialist in vascular medecine	Annecy
France	Hospital center Armentières	Armentières
France	Office-based Specialist in vascular medecine	Arpajon
France	Office-based Specialist in vascular medecine	Auxerre
France	Office-based Specialist in vascular medecine	Basse-terre (Guadeloupe)
France	Office-based Specialist in vascular medecine	Beauvais
France	Office-based Specialist in vascular medecine	Blagnac
France	Hospital Saint-André	Bordeaux
France	Office-based Specialist in vascular medecine	Bordeaux
France	Hospital center	Boulogne Sur Mer
France	Office-based Specialist in vascular medecine	Bourg-en-Bresse
France	Office-based Specialist in vascular medecine	Bourgoin-Jallieu
France	Office-based Specialist in vascular medecine	Brest
France	University Hospital Brest	Brest
France	Office-based Specialist in vascular medecine	Bretigny
France	Hospital center	Brive La Gaillarde
France	University Hospital Caen	Caen
France	Office-based Specialist in vascular medecine	Cannes
France	Hospital Antoine Gayraud	Carcassonne
France	Office-based Specialist in vascular medecine	Carcassonne
France	Office-based Specialist in vascular medecine	Castres
France	Office-based Specialist in vascular medecine	Ceyrat
France	Office-based Specialist in vascular medecine	Chalon-sur-Saone
France	Office-based Specialist in vascular medecine	Chambéry
France	Office-based Specialist in vascular medecine	Chartres
France	Hospital Center Versailles	Chesnay
France	Office-based Specialist in vascular medecine	Cholet
France	Office-based Specialist in vascular medecine	Clermont-Ferrand
France	Office-based Specialist in vascular medecine	Cluses
France	Office-based Specialist in vascular medecine	Cognac
France	Hospital Center Compiègne	Compiègne
France	Office-based Specialist in vascular medecine	Crolles
France	Office-based Specialist in vascular medecine	Denain
France	Bocage Hospital	Dijon
France	Office-based Specialist in vascular medecine	Ermont
France	Office-based Specialist in vascular medecine	EU
France	Office-based Specialist in vascular medecine	Fecamp
France	Hospital center Val d'Ariège	Foix
France	Office-based Specialist in vascular medecine	Fort de France
France	Office-based Specialist in vascular medecine	Grenoble
France	University Hospital Grenoble	Grenoble
France	Office-based Specialist in vascular medecine	Issy les Moulineaux
France	Office-based Specialist in vascular medecine	La Membrolle
France	Office-based Specialist in vascular medecine	La Rochelle
France	Hospital Center Lens	Lens
France	Office-based Specialist in vascular medecine	Levallois-Perret
France	University Hospital Lille	Lille
France	Office-based Specialist in vascular medecine	Limoges
France	University Hospital Limoges	Limoges
France	Hospital Saint Philibert	Lomme
France	Office-based Specialist in vascular medecine	Lomme
France	Office-based Specialist in vascular medecine	Longwy
France	Edouard Herriot Hospital	Lyon
France	Office-based Specialist in vascular medecine	Lyon
France	Office-based Specialist in vascular medecine	Malemort-sur-Correze
France	Office-based Specialist in vascular medecine	Maubeuge
France	Hospital of Belfort	Montbéliard
France	Office-based Specialist in vascular medecine	Montelimar
France	Office-based Specialist in vascular medecine	Montluçon
France	University hospital Montpellier	Montpellier
France	Office-based Specialist in vascular medecine	Mulhouse
France	Office-based Specialist in vascular medecine	Nice
France	Office-based Specialist in vascular medecine	Niort
France	Office-based Specialist in vascular medecine	Noumea
France	Office-based Specialist in vascular medecine	Orleans
France	Hospital Center	Orléans
France	Hospital center Territorial Mamao	Papeete
France	Office-based Specialist in vascular medecine	Paris
France	Hospital Center	Périgueux
France	Office-based Specialist in vascular medecine	Peronne
France	Office-based Specialist in vascular medecine	Perpignan
France	Office-based Specialist in vascular medecine	Pontcharra
France	Office-based Specialist in vascular medecine	Pornic
France	Office-based Specialist in vascular medecine	Puilboreau
France	Office-based Specialist in vascular medecine	Rambouillet
France	Office-based Specialist in vascular medecine	Rochefort
France	Hospital center Rodez	Rodez
France	Office-based Specialist in vascular medecine	Rodez
France	Office-based Specialist in vascular medecine	Rouen
France	Office-based Specialist in vascular medecine	Saint Aubin de Medoc
France	Office-based Specialist in vascular medecine	Saint Aubin sur Scie
France	Office-based Specialist in vascular medecine	Saint benoît
France	University Hospital Saint Etienne	Saint Etienne
France	Office-based Specialist in vascular medecine	Saint-Etienne
France	Memorial Hospital	Saint-Lo
France	Office-based Specialist in vascular medecine	Saint-Lo
France	Office-based Specialist in vascular medecine	Saint-Priest
France	Hospital	Saint-Quentin
France	Office-based Specialist in vascular medecine	Sallanches
France	Office-based Specialist in vascular medecine	Sarcelles
France	Office-based Specialist in vascular medecine	Sarrebourg
France	Office-based Specialist in vascular medecine	Sarreguemines
France	Office-based Specialist in vascular medecine	Savigny-sur-Orge
France	Office-based Specialist in vascular medecine	Selestat
France	Office-based Specialist in vascular medecine	Strasbourg
France	Office-based Specialist in vascular medecine	Toulon
France	Office-based Specialist in vascular medecine	Toulouse
France	University Hospital Rangueil	Toulouse
France	Office-based Specialist in vascular medecine	Tours
France	Office-based Specialist in vascular medecine	Trelaze
France	Office-based Specialist in vascular medecine	Trois-Rivières (Guadeloupe)
France	Office-based Specialist in vascular medecine	Vannes
France	Office-based Specialist in vascular medecine	Versailles
France	Office-based Specialist in vascular medecine	Vienne
France	Office-based Specialist in vascular medecine	Villeurbanne
France	Office-based Specialist in vascular medecine	Vincennes
France	Office-based Specialist in vascular medecine	Vizille
France	Office-based Specialist in vascular medecine	Voiron
France	Office-based Specialist in vascular medecine	Wissembourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de l'Atherothrombose

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm		evaluation during inclusion visit	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	incidence and cardiovascular risk factor		3 months, 1, 2 and 3 years	Yes
Secondary	incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations		3 Months, 1, 2 and 3 years	Yes
Secondary	useful of the screening	decision analysis	3 years	No