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

March 5, 2015 updated by: Institut de l'Atherothrombose
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1056

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Chênée, Belgium, 04032
        • University Hospital Liege
  • France
      • Abbeville, France, 80100
        • Hospital
      • Alençon, France, 61000
        • Office-based Specialist in vascular medecine
      • Ambarès et Lagrave, France, 33440
        • Office-based Specialist in vascular medecine
      • Amiens, France, 80054
        • University Hospital Amiens
      • Amiens, France, 80094
        • Office-based Specialist in vascular medecine
      • Annecy, France, 74000
        • Office-based Specialist in vascular medecine
      • Armentières, France, 59280
        • Hospital center Armentières
      • Arpajon, France, 91290
        • Office-based Specialist in vascular medecine
      • Auxerre, France, 89000
        • Office-based Specialist in vascular medecine
      • Basse-terre (Guadeloupe), France, 97100
        • Office-based Specialist in vascular medecine
      • Beauvais, France, 60000
        • Office-based Specialist in vascular medecine
      • Blagnac, France, 31700
        • Office-based Specialist in vascular medecine
      • Bordeaux, France, 33075
        • Hospital Saint-André
      • Bordeaux, France, 33300
        • Office-based Specialist in vascular medecine
      • Boulogne Sur Mer, France, 62321
        • Hospital center
      • Bourg-en-Bresse, France, 01000
        • Office-based Specialist in vascular medecine
      • Bourgoin-Jallieu, France, 38300
        • Office-based Specialist in vascular medecine
      • Brest, France, 29609
        • University Hospital Brest
      • Brest, France, 29200
        • Office-based Specialist in vascular medecine
      • Bretigny, France, 91220
        • Office-based Specialist in vascular medecine
      • Brive La Gaillarde, France, 19312
        • Hospital center
      • Caen, France, 14033
        • University Hospital Caen
      • Cannes, France, 06400
        • Office-based Specialist in vascular medecine
      • Carcassonne, France, 11000
        • Office-based Specialist in vascular medecine
      • Carcassonne, France, 11890
        • Hospital Antoine Gayraud
      • Castres, France, 81100
        • Office-based Specialist in vascular medecine
      • Ceyrat, France, 63122
        • Office-based Specialist in vascular medecine
      • Chalon-sur-Saone, France, 71100
        • Office-based Specialist in vascular medecine
      • Chambéry, France, 73000
        • Office-based Specialist in vascular medecine
      • Chartres, France, 28000
        • Office-based Specialist in vascular medecine
      • Chesnay, France, 78150
        • Hospital Center Versailles
      • Cholet, France, 49300
        • Office-based Specialist in vascular medecine
      • Clermont-Ferrand, France, 63000
        • Office-based Specialist in vascular medecine
      • Cluses, France, 74300
        • Office-based Specialist in vascular medecine
      • Cognac, France, 16100
        • Office-based Specialist in vascular medecine
      • Compiègne, France, 60321
        • Hospital Center Compiègne
      • Crolles, France, 38920
        • Office-based Specialist in vascular medecine
      • Denain, France, 59220
        • Office-based Specialist in vascular medecine
      • Dijon, France, 21079
        • Bocage Hospital
      • EU, France, 76260
        • Office-based Specialist in vascular medecine
      • Ermont, France, 95120
        • Office-based Specialist in vascular medecine
      • Fecamp, France, 76400
        • Office-based Specialist in vascular medecine
      • Foix, France, 09000
        • Hospital center Val d'Ariège
      • Fort de France, France, 97200
        • Office-based Specialist in vascular medecine
      • Grenoble, France, 38043
        • University Hospital Grenoble
      • Grenoble, France, 38000
        • Office-based Specialist in vascular medecine
      • Issy les Moulineaux, France, 92130
        • Office-based Specialist in vascular medecine
      • La Membrolle, France, 49770
        • Office-based Specialist in vascular medecine
      • La Rochelle, France, 17000
        • Office-based Specialist in vascular medecine
      • Lens, France, 62307
        • Hospital Center Lens
      • Levallois-Perret, France, 92300
        • Office-based Specialist in vascular medecine
      • Lille, France, 59037
        • University Hospital Lille
      • Limoges, France, 87042
        • University Hospital Limoges
      • Limoges, France, 87100
        • Office-based Specialist in vascular medecine
      • Lomme, France, 59462
        • Hospital Saint Philibert
      • Lomme, France, 59160
        • Office-based Specialist in vascular medecine
      • Longwy, France, 54440
        • Office-based Specialist in vascular medecine
      • Lyon, France, 69003
        • Edouard Herriot Hospital
      • Lyon, France, 69007
        • Office-based Specialist in vascular medecine
      • Malemort-sur-Correze, France, 19360
        • Office-based Specialist in vascular medecine
      • Maubeuge, France, 59600
        • Office-based Specialist in vascular medecine
      • Montbéliard, France, 25200
        • Hospital of Belfort
      • Montelimar, France, 26200
        • Office-based Specialist in vascular medecine
      • Montluçon, France, 03100
        • Office-based Specialist in vascular medecine
      • Montpellier, France, 34295
        • University Hospital Montpellier
      • Mulhouse, France, 68200
        • Office-based Specialist in vascular medecine
      • Nice, France, 06000
        • Office-based Specialist in vascular medecine
      • Niort, France, 79000
        • Office-based Specialist in vascular medecine
      • Noumea, France, 98895
        • Office-based Specialist in vascular medecine
      • Orleans, France, 45100
        • Office-based Specialist in vascular medecine
      • Orléans, France, 45000
        • Hospital center
      • Papeete, France, 98713
        • Hospital center Territorial Mamao
      • Paris, France, 75116
        • Office-based Specialist in vascular medecine
      • Peronne, France, 80200
        • Office-based Specialist in vascular medecine
      • Perpignan, France, 66000
        • Office-based Specialist in vascular medecine
      • Pontcharra, France, 38530
        • Office-based Specialist in vascular medecine
      • Pornic, France, 44210
        • Office-based Specialist in vascular medecine
      • Puilboreau, France, 17138
        • Office-based Specialist in vascular medecine
      • Périgueux, France, 24000
        • Hospital center
      • Rambouillet, France, 78120
        • Office-based Specialist in vascular medecine
      • Rochefort, France, 17300
        • Office-based Specialist in vascular medecine
      • Rodez, France, 12000
        • Office-based Specialist in vascular medecine
      • Rodez, France, 12027
        • Hospital center Rodez
      • Rouen, France, 76100
        • Office-based Specialist in vascular medecine
      • Saint Aubin de Medoc, France, 33160
        • Office-based Specialist in vascular medecine
      • Saint Aubin sur Scie, France, 76550
        • Office-based Specialist in vascular medecine
      • Saint Etienne, France, 42100
        • University Hospital Saint Etienne
      • Saint benoît, France, 86280
        • Office-based Specialist in vascular medecine
      • Saint-Etienne, France, 42000
        • Office-based Specialist in vascular medecine
      • Saint-Lo, France, 50000
        • Memorial Hospital
      • Saint-Lo, France, 50000
        • Office-based Specialist in vascular medecine
      • Saint-Priest, France, 69800
        • Office-based Specialist in vascular medecine
      • Saint-Quentin, France, 02100
        • Hospital
      • Sallanches, France, 74700
        • Office-based Specialist in vascular medecine
      • Sarcelles, France, 95200
        • Office-based Specialist in vascular medecine
      • Sarrebourg, France, 57400
        • Office-based Specialist in vascular medecine
      • Sarreguemines, France, 57200
        • Office-based Specialist in vascular medecine
      • Savigny-sur-Orge, France, 91600
        • Office-based Specialist in vascular medecine
      • Selestat, France, 67600
        • Office-based Specialist in vascular medecine
      • Strasbourg, France, 67000
        • Office-based Specialist in vascular medecine
      • Toulon, France, 83000
        • Office-based Specialist in vascular medecine
      • Toulouse, France, 31059
        • University Hospital Rangueil
      • Toulouse, France, 31076
        • Office-based Specialist in vascular medecine
      • Tours, France, 37000
        • Office-based Specialist in vascular medecine
      • Trelaze, France, 49800
        • Office-based Specialist in vascular medecine
      • Trois-Rivières (Guadeloupe), France, 97114
        • Office-based Specialist in vascular medecine
      • Vannes, France, 56000
        • Office-based Specialist in vascular medecine
      • Versailles, France, 78000
        • Office-based Specialist in vascular medecine
      • Vienne, France, 38200
        • Office-based Specialist in vascular medecine
      • Villeurbanne, France, 69100
        • Office-based Specialist in vascular medecine
      • Vincennes, France, 94300
        • Office-based Specialist in vascular medecine
      • Vizille, France, 38220
        • Office-based Specialist in vascular medecine
      • Voiron, France, 38500
        • Office-based Specialist in vascular medecine
      • Wissembourg, France, 67160
        • Office-based Specialist in vascular medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
patient with newly diagnosed PAD (< 1 year)
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
Other Names:
  • arterial disease of the lower limbs
  • carotid stenosis
  • aortic aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: evaluation during inclusion visit
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
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
evaluation during inclusion visit
incidence and cardiovascular risk factor
Time Frame: 3 months, 1, 2 and 3 years
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
3 Months, 1, 2 and 3 years
useful of the screening
Time Frame: 3 years
decision analysis
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de l'Atherothrombose

Investigators

  • Principal Investigator: Patrick CARPENTIER, Professor, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (ESTIMATE)

October 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 0704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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