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Completed

NCT Number: NCT01224600

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patients with newly diagnosed PAD (<1year)

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. incidence and cardiovascular risk factor

    Time frame: 3 months, 1, 2 and 3 years

  5. incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations

    Time frame: 3 Months, 1, 2 and 3 years

  6. useful of the screening

    Time frame: 3 years

    decision analysis

Sponsors and collaborators

Lead sponsor

Institut de l'Atherothrombose

Other

Registry information

Acronym: EVART

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
Oct 20, 2010
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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