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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2015
• Main ID: NCT01224600
• Date of registration: 15/09/2010
• Prospective Registration: No
• Primary sponsor: Institut de l'Atherothrombose
• Public title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs EVART
• Scientific title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs
• Date of first enrolment: January 2008
• Target sample size: 1056
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01224600
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Belgium, France

Contacts

• Name: Patrick CARPENTIER, Professor
• Affiliation: University Hospital, Grenoble

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Carotid Stenosis

Abdominal Aortic Aneurysm

Intervention(s)

Other: patients with newly diagnosed PAD (<1year)

Primary Outcome(s)

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(s)

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]

incidence and cardiovascular risk factor [Time Frame: 3 months, 1, 2 and 3 years]

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 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 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]

Secondary ID(s)

DCIC 0704

Source(s) of Monetary Support

Please refer to primary and secondary sponsors