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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224600
First Posted: October 20, 2010
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut de l'Atherothrombose
  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 ]

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 ]
  • 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 ]
  • 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 ]
  • incidence and cardiovascular risk factor [ Time Frame: 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 ]
  • useful of the screening [ Time Frame: 3 years ]
    decision analysis


Enrollment: 1056
Study Start Date: January 2008
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224600


  Show 115 Study Locations
Sponsors and Collaborators
Institut de l'Atherothrombose
Investigators
Principal Investigator: Patrick CARPENTIER, Professor University Hospital, Grenoble
  More Information

Responsible Party: Institut de l'Atherothrombose
ClinicalTrials.gov Identifier: NCT01224600     History of Changes
Other Study ID Numbers: DCIC 0704
First Submitted: September 15, 2010
First Posted: October 20, 2010
Last Update Posted: March 6, 2015
Last Verified: March 2015

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

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