EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs (EVART)
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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 |
- 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 ]
- 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:
|
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 |
Patients with newly diagnosed PAD < 1 year symptomatic or asymptomatic without any hystory of previous coronary nor cerebrovascular event
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
Show 115 Study Locations| 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:
|
Aneurysm Aortic Aneurysm Carotid Stenosis Peripheral Arterial Disease Peripheral Vascular Diseases Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Aortic Diseases |
Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Atherosclerosis Arteriosclerosis |
ClinicalTrials.gov processed this record on May 21, 2013