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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Institut de l'Atherothrombose.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Institut de l'Atherothrombose
ClinicalTrials.gov Identifier:
NCT01224600
First received: September 15, 2010
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Carotid Stenosis
Abdominal Aortic Aneurysm
Other: patients with newly diagnosed PAD (<1year)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

Resource links provided by NLM:


Further study details as provided by Institut de l'Atherothrombose:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • incidence and cardiovascular risk factor [ Time Frame: 3 months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations [ Time Frame: 3 Months, 1, 2 and 3 years ] [ Designated as safety issue: Yes ]
  • useful of the screening [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    decision analysis


Enrollment: 1055
Study Start Date: October 2008
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224600

  Hide Study Locations
Locations
Belgium
University hospital Liège
Chênée, Belgium, 04032
France
Hospital
Abbeville, France, 80100
Office-based Specialist in vascular medecine
Alençon, France, 61000
Office-based Specialist in vascular medecine
Ambarès et Lagrave, France, 33440
Office-based Specialist in vascular medecine
Amiens, France, 80094
University Hospital Amiens
Amiens, France, 80054
Office-based Specialist in vascular medecine
Annecy, France, 74000
Hospital center Armentières
Armentières, France, 59280
Office-based Specialist in vascular medecine
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, 33300
Hospital Saint-André
Bordeaux, France, 33075
Hospital center
Boulogne Sur Mer, France, 62321
Office-based Specialist in vascular medecine
Bourg-en-Bresse, France, 01000
Office-based Specialist in vascular medecine
Bourgoin-Jallieu, France, 38300
University Hospital Brest
Brest, France, 29609
Office-based Specialist in vascular medecine
Brest, France, 29200
Office-based Specialist in vascular medecine
Bretigny, France, 91220
Hospital center
Brive La Gaillarde, France, 19312
University Hospital Caen
Caen, France, 14033
Office-based Specialist in vascular medecine
Cannes, France, 06400
Office-based Specialist in vascular medecine
Carcassonne, France, 11000
Hospital Antoine Gayraud
Carcassonne, France, 11890
Office-based Specialist in vascular medecine
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
Hospital Center Versailles
Chesnay, France, 78150
Office-based Specialist in vascular medecine
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
Hospital Center Compiègne
Compiègne, France, 60321
Office-based Specialist in vascular medecine
Crolles, France, 38920
Office-based Specialist in vascular medecine
Denain, France, 59220
Bocage Hospital
Dijon, France, 21079
Office-based Specialist in vascular medecine
Ermont, France, 95120
Office-based Specialist in vascular medecine
EU, France, 76260
Office-based Specialist in vascular medecine
Fecamp, France, 76400
Hospital center Val d'Ariège
Foix, France, 09000
Office-based Specialist in vascular medecine
Fort de France, France, 97200
University Hospital Grenoble
Grenoble, France, 38043
Office-based Specialist in vascular medecine
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
Hospital Center Lens
Lens, France, 62307
Office-based Specialist in vascular medecine
Levallois-Perret, France, 92300
University Hospital Lille
Lille, France, 59037
Office-based Specialist in vascular medecine
Limoges, France, 87100
University Hospital Limoges
Limoges, France, 87042
Office-based Specialist in vascular medecine
Lomme, France, 59160
Hospital Saint Philibert
Lomme, France, 59462
Office-based Specialist in vascular medecine
Longwy, France, 54440
Office-based Specialist in vascular medecine
Lyon, France, 69007
Edouard Herriot Hospital
Lyon, France, 69003
Office-based Specialist in vascular medecine
Malemort-sur-Correze, France, 19360
Office-based Specialist in vascular medecine
Maubeuge, France, 59600
Hospital of Belfort
Montbéliard, France, 25200
Office-based Specialist in vascular medecine
Montelimar, France, 26200
Office-based Specialist in vascular medecine
Montluçon, France, 03100
University hospital Montpellier
Montpellier, France, 34295
Office-based Specialist in vascular medecine
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
Hospital Center
Orléans, France, 45000
Hospital center Territorial Mamao
Papeete, France, 98713
Office-based Specialist in vascular medecine
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
Hospital Center
Périgueux, France, 24000
Office-based Specialist in vascular medecine
Rambouillet, France, 78120
Office-based Specialist in vascular medecine
Rochefort, France, 17300
Hospital center Rodez
Rodez, France, 12027
Office-based Specialist in vascular medecine
Rodez, France, 12000
Office-based Specialist in vascular medecine
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 benoît, France, 86280
University Hospital Saint Etienne
Saint Etienne, France, 42100
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
Hospital
Saint-Quentin, France, 02100
Office-based Specialist in vascular medecine
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
University Hospital Rangueil
Toulouse, France, 31059
Office-based Specialist in vascular medecine
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
Sponsors and Collaborators
Institut de l'Atherothrombose
Investigators
Principal Investigator: Patrick CARPENTIER, Professor University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: CARPENTIER Patrick, MD, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT01224600     History of Changes
Other Study ID Numbers: DCIC 0704
Study First Received: September 15, 2010
Last Updated: March 7, 2011
Health Authority: France: French Data Protection Authority

Keywords provided by Institut de l'Atherothrombose:
lower limbs
Arterial Diseases

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Carotid Stenosis
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aneurysm
Aortic Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014