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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01224600
Acronym
EVART
Enrollment
1056
Registered
2010-10-20
Start date
2008-01-31
Completion date
2014-03-31
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm, Carotid Stenosis, Peripheral Arterial Disease

Keywords

lower limbs, Arterial Diseases

Brief summary

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.

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.

Interventions

OTHERpatients 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

Sponsors

Institut de l'Atherothrombose
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysmevaluation during inclusion visit

Secondary

MeasureTime frameDescription
frequency of prescription of cardiac consultation,coronarography, stress ECG, stress echo, thallium scan and renal and digestive doppler ultrasound. Frequency of coronary and renal revascularizationevaluation 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 managementevaluation during inclusion visit
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 factorevaluation during inclusion visit
incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations3 Months, 1, 2 and 3 years
useful of the screening3 yearsdecision analysis
incidence and cardiovascular risk factor3 months, 1, 2 and 3 years

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026