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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

September 15, 2010
March 7, 2011
October 2008
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01224600 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with newly diagnosed PAD < 1 year symptomatic or asymptomatic without any hystory of previous coronary nor cerebrovascular event

  • Peripheral Arterial Disease
  • Carotid Stenosis
  • Abdominal Aortic Aneurysm
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
1
patient with newly diagnosed PAD (< 1 year)
Intervention: Other: patients with newly diagnosed PAD (<1year)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1055
March 2014
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT01224600
DCIC 0704
Yes
CARPENTIER Patrick, MD, University Hospital Grenoble
Institut de l'Atherothrombose
Not Provided
Principal Investigator: Patrick CARPENTIER, Professor University Hospital, Grenoble
Institut de l'Atherothrombose
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP