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

  Show 115 Study Locations
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
Peripheral Arterial Disease
Peripheral Vascular Diseases
Carotid Stenosis
Aneurysm
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

ClinicalTrials.gov processed this record on September 16, 2014