Peripheral Arterial DiseaseEVARTNCT01224600
EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs
An observational study of Peripheral Arterial Disease and Carotid Stenosis, run by Institut de l'Atherothrombose at 115 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Carotid Stenosis, Abdominal Aortic Aneurysm
- What is being tested?
- patients with newly diagnosed PAD (<1year)
- How many people
- 1,056 participants
- Where
- 115 sitesin 2 countries
- Study dates
- Jan 2008to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed PAD < 1 year symptomatic or asymptomatic without any hystory of previous coronary nor cerebrovascular event
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
115 sites in 2 countries.
115 sites in 2 countries
France114 sites
Hospital
Abbeville, 80100
Office-based Specialist in vascular medecine
Alençon, 61000
Office-based Specialist in vascular medecine
Ambarès-et-Lagrave, 33440
University Hospital Amiens
Amiens, 80054
Office-based Specialist in vascular medecine
Amiens, 80094
Office-based Specialist in vascular medecine
Annecy, 74000
Hospital center Armentières
Armentières, 59280
Office-based Specialist in vascular medecine
Arpajon, 91290
Office-based Specialist in vascular medecine
Auxerre, 89000
Office-based Specialist in vascular medecine
Basse-terre (Guadeloupe), 97100
Office-based Specialist in vascular medecine
Beauvais, 60000
Office-based Specialist in vascular medecine
Blagnac, 31700
Hospital Saint-André
Bordeaux, 33075
Office-based Specialist in vascular medecine
Bordeaux, 33300
Hospital center
Boulogne-sur-Mer, 62321
Office-based Specialist in vascular medecine
Bourg-en-Bresse, 01000
Office-based Specialist in vascular medecine
Bourgoin, 38300
Office-based Specialist in vascular medecine
Brest, 29200
University Hospital Brest
Brest, 29609
Office-based Specialist in vascular medecine
Bretigny, 91220
Hospital center
Brive-la-Gaillarde, 19312
University Hospital Caen
Caen, 14033
Office-based Specialist in vascular medecine
Cannes, 06400
Office-based Specialist in vascular medecine
Carcassonne, 11000
Hospital Antoine Gayraud
Carcassonne, 11890
Office-based Specialist in vascular medecine
Castres, 81100
Office-based Specialist in vascular medecine
Ceyrat, 63122
Office-based Specialist in vascular medecine
Chalon-sur-Saône, 71100
Office-based Specialist in vascular medecine
Chambéry, 73000
Office-based Specialist in vascular medecine
Chartres, 28000
Hospital Center Versailles
Chesnay, 78150
Office-based Specialist in vascular medecine
Cholet, 49300
Office-based Specialist in vascular medecine
Clermont-Ferrand, 63000
Office-based Specialist in vascular medecine
Cluses, 74300
Office-based Specialist in vascular medecine
Cognac, 16100
Hospital Center Compiègne
Compiègne, 60321
Office-based Specialist in vascular medecine
Crolles, 38920
Office-based Specialist in vascular medecine
Denain, 59220
Bocage Hospital
Dijon, 21079
Office-based Specialist in vascular medecine
Ermont, 95120
Office-based Specialist in vascular medecine
Eu, 76260
Office-based Specialist in vascular medecine
Fécamp, 76400
Hospital center Val d'Ariège
Foix, 09000
Office-based Specialist in vascular medecine
Fort de France, 97200
Office-based Specialist in vascular medecine
Grenoble, 38000
University Hospital Grenoble
Grenoble, 38043
Office-based Specialist in vascular medecine
Issy-les-Moulineaux, 92130
Office-based Specialist in vascular medecine
La Membrolle-sur-Choisille, 49770
Office-based Specialist in vascular medecine
La Rochelle, 17000
Hospital Center Lens
Lens, 62307
Office-based Specialist in vascular medecine
Levallois-Perret, 92300
University Hospital Lille
Lille, 59037
University Hospital Limoges
Limoges, 87042
Office-based Specialist in vascular medecine
Limoges, 87100
Office-based Specialist in vascular medecine
Lomme, 59160
Hospital Saint Philibert
Lomme, 59462
Office-based Specialist in vascular medecine
Longwy, 54440
Edouard Herriot Hospital
Lyon, 69003
Office-based Specialist in vascular medecine
Lyon, 69007
Office-based Specialist in vascular medecine
Malemort-sur-Corrèze, 19360
Office-based Specialist in vascular medecine
Maubeuge, 59600
Hospital of Belfort
Montbéliard, 25200
Office-based Specialist in vascular medecine
Montélimar, 26200
Office-based Specialist in vascular medecine
Montluçon, 03100
University hospital Montpellier
Montpellier, 34295
Office-based Specialist in vascular medecine
Mulhouse, 68200
Office-based Specialist in vascular medecine
Nice, 06000
Office-based Specialist in vascular medecine
Niort, 79000
Office-based Specialist in vascular medecine
Noumea, 98895
Hospital Center
Orléans, 45000
Office-based Specialist in vascular medecine
Orléans, 45100
Hospital center Territorial Mamao
Papeete, 98713
Office-based Specialist in vascular medecine
Paris, 75116
Hospital Center
Périgueux, 24000
Office-based Specialist in vascular medecine
Péronne, 80200
Office-based Specialist in vascular medecine
Perpignan, 66000
Office-based Specialist in vascular medecine
Pontcharra, 38530
Office-based Specialist in vascular medecine
Pornic, 44210
Office-based Specialist in vascular medecine
Puilboreau, 17138
Office-based Specialist in vascular medecine
Rambouillet, 78120
Office-based Specialist in vascular medecine
Rochefort, 17300
Office-based Specialist in vascular medecine
Rodez, 12000
Hospital center Rodez
Rodez, 12027
Office-based Specialist in vascular medecine
Rouen, 76100
Office-based Specialist in vascular medecine
Saint-Aubin-de-Médoc, 33160
Office-based Specialist in vascular medecine
Saint-Aubin-sur-Scie, 76550
Office-based Specialist in vascular medecine
Saint-Benoît, 86280
Office-based Specialist in vascular medecine
Saint-Etienne, 42000
University Hospital Saint Etienne
Saint-Etienne, 42100
Memorial Hospital
Saint-Lô, 50000
Office-based Specialist in vascular medecine
Saint-Lô, 50000
Office-based Specialist in vascular medecine
Saint-Priest, 69800
Hospital
Saint-Quentin, 02100
Office-based Specialist in vascular medecine
Sallanches, 74700
Office-based Specialist in vascular medecine
Sarcelles, 95200
Office-based Specialist in vascular medecine
Sarrebourg, 57400
Office-based Specialist in vascular medecine
Sarreguemines, 57200
Office-based Specialist in vascular medecine
Savigny-sur-Orge, 91600
Office-based Specialist in vascular medecine
Sélestat, 67600
Office-based Specialist in vascular medecine
Strasbourg, 67000
Office-based Specialist in vascular medecine
Toulon, 83000
University Hospital Rangueil
Toulouse, 31059
Office-based Specialist in vascular medecine
Toulouse, 31076
Office-based Specialist in vascular medecine
Tours, 37000
Office-based Specialist in vascular medecine
Trélazé, 49800
Office-based Specialist in vascular medecine
Trois-Rivières (Guadeloupe), 97114
Office-based Specialist in vascular medecine
Vannes, 56000
Office-based Specialist in vascular medecine
Versailles, 78000
Office-based Specialist in vascular medecine
Vienne, 38200
Office-based Specialist in vascular medecine
Villeurbanne, 69100
Office-based Specialist in vascular medecine
Vincennes, 94300
Office-based Specialist in vascular medecine
Vizille, 38220
Office-based Specialist in vascular medecine
Voiron, 38500
Office-based Specialist in vascular medecine
Wissembourg, 67160
About this study
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.
Read the 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.
- Being tested
- patients with newly diagnosed PAD (<1year)
- Keywords
- lower limbs, Arterial Diseases
- Medical subject headings
- Peripheral Arterial Disease, Carotid Stenosis, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with newly diagnosed PAD (<1year)Other
Also called arterial disease of the lower limbs, carotid stenosis, aortic aneurysm
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | patient with newly diagnosed PAD (< 1 year) Receives: Other: patients with newly diagnosed PAD (<1year) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm
Measured: evaluation during inclusion visit
Secondary outcomes (6)
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
Measured: evaluation during inclusion visit
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
Measured: 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
Measured: evaluation during inclusion visit
incidence and cardiovascular risk factor
Measured: 3 months, 1, 2 and 3 years
incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations
Measured: 3 Months, 1, 2 and 3 years
useful of the screening
decision analysis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de l'Atherothrombose
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick CARPENTIER, Professor, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224600
- Sponsor's protocol ID
- DCIC 0704
- Acronym
- EVART
- Status last verified
- Mar 2015
- First submitted
- 15 Sep 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs
- ClinicalTrials.gov ID
- NCT01224600
- Acronym / sponsor ID
- EVART / DCIC 0704
- Keywords
- lower limbs, Arterial Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Institut de l'AtherothromboseUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: patients with newly diagnosed PAD (<1year)patient with newly diagnosed PAD (< 1 year) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed PAD < 1 year symptomatic or asymptomatic without any hystory of previous coronary nor cerebrovascular event
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients with newly diagnosed PAD (<1year)Also: arterial disease of the lower limbs, carotid stenosis, aortic aneurysmpatients 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 | 1 |
Primary outcome
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
6 secondary outcomes
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 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
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 and cardiovascular risk factor
Time frame: 3 months, 1, 2 and 3 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick CARPENTIER, Professor principal investigator
University Hospital, Grenoble
115 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Carotid Stenosis, run by Institut de l'Atherothrombose at 115 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.