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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de l'Atherothrombose

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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