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

NCT01224600 | Completed DMC

• 1 other identifier: DCIC 0704
• Study Type: observational
• Target: 1,056
• Locations: 2 countries
• Sites: 115

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.

Conditions

Peripheral Arterial Disease; Carotid Stenosis; Abdominal Aortic Aneurysm

Keywords

lower limbs; Arterial Diseases

Outcome Measures

Primary Outcomes (1)

• prevalence and risk factors, at the time of the diagnosis PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm

  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

  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

  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

  evaluation during inclusion visit

• incidence and cardiovascular risk factor

  3 months, 1, 2 and 3 years

• incidence of thromboembolic disease (symptomatic DVT and/or PE) proved by additional examinations

  3 Months, 1, 2 and 3 years

Study Arms (1)

1

patient with newly diagnosed PAD (\< 1 year)

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

Interventions

patients with newly diagnosed PAD (<1year) OTHER

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

Also known as: arterial disease of the lower limbs, carotid stenosis, aortic aneurysm

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de l'Atherothrombose: lead

Study Sites (115)

University hospital Liège

Chênée, 04032, Belgium

Location

Hospital

Abbeville, 80100, France

Location

Office-based Specialist in vascular medecine

Alençon, 61000, France

Location

Office-based Specialist in vascular medecine

Ambarès-et-Lagrave, 33440, France

Location

University Hospital Amiens

Amiens, 80054, France

Location

Office-based Specialist in vascular medecine

Amiens, 80094, France

Location

Office-based Specialist in vascular medecine

Annecy, 74000, France

Location

Hospital center Armentières

Armentières, 59280, France

Location

Office-based Specialist in vascular medecine

Arpajon, 91290, France

Location

Office-based Specialist in vascular medecine

Auxerre, 89000, France

Location

Office-based Specialist in vascular medecine

Basse-terre (Guadeloupe), 97100, France

Location

Office-based Specialist in vascular medecine

Beauvais, 60000, France

Location

Office-based Specialist in vascular medecine

Blagnac, 31700, France

Location

Hospital Saint-André

Bordeaux, 33075, France

Location

Office-based Specialist in vascular medecine

Bordeaux, 33300, France

Location

Hospital center

Boulogne-sur-Mer, 62321, France

Location

Office-based Specialist in vascular medecine

Bourg-en-Bresse, 01000, France

Location

Office-based Specialist in vascular medecine

Bourgoin, 38300, France

Location

Office-based Specialist in vascular medecine

Brest, 29200, France

Location

University Hospital Brest

Brest, 29609, France

Location

Office-based Specialist in vascular medecine

Bretigny, 91220, France

Location

Hospital center

Brive-la-Gaillarde, 19312, France

Location

University Hospital Caen

Caen, 14033, France

Location

Office-based Specialist in vascular medecine

Cannes, 06400, France

Location

Office-based Specialist in vascular medecine

Carcassonne, 11000, France

Location

Hospital Antoine Gayraud

Carcassonne, 11890, France

Location

Office-based Specialist in vascular medecine

Castres, 81100, France

Location

Office-based Specialist in vascular medecine

Ceyrat, 63122, France

Location

Office-based Specialist in vascular medecine

Chalon-sur-Saône, 71100, France

Location

Office-based Specialist in vascular medecine

Chambéry, 73000, France

Location

Office-based Specialist in vascular medecine

Chartres, 28000, France

Location

Hospital Center Versailles

Chesnay, 78150, France

Location

Office-based Specialist in vascular medecine

Cholet, 49300, France

Location

Office-based Specialist in vascular medecine

Clermont-Ferrand, 63000, France

Location

Office-based Specialist in vascular medecine

Cluses, 74300, France

Location

Office-based Specialist in vascular medecine

Cognac, 16100, France

Location

Hospital Center Compiègne

Compiègne, 60321, France

Location

Office-based Specialist in vascular medecine

Crolles, 38920, France

Location

Office-based Specialist in vascular medecine

Denain, 59220, France

Location

Bocage Hospital

Dijon, 21079, France

Location

Office-based Specialist in vascular medecine

Ermont, 95120, France

Location

Office-based Specialist in vascular medecine

Eu, 76260, France

Location

Office-based Specialist in vascular medecine

Fécamp, 76400, France

Location

Hospital center Val d'Ariège

Foix, 09000, France

Location

Office-based Specialist in vascular medecine

Fort de France, 97200, France

Location

Office-based Specialist in vascular medecine

Grenoble, 38000, France

Location

University Hospital Grenoble

Grenoble, 38043, France

Location

Office-based Specialist in vascular medecine

Issy-les-Moulineaux, 92130, France

Location

Office-based Specialist in vascular medecine

La Membrolle-sur-Choisille, 49770, France

Location

Office-based Specialist in vascular medecine

La Rochelle, 17000, France

Location

Hospital Center Lens

Lens, 62307, France

Location

Office-based Specialist in vascular medecine

Levallois-Perret, 92300, France

Location

University Hospital Lille

Lille, 59037, France

Location

University Hospital Limoges

Limoges, 87042, France

Location

Office-based Specialist in vascular medecine

Limoges, 87100, France

Location

Office-based Specialist in vascular medecine

Lomme, 59160, France

Location

Hospital Saint Philibert

Lomme, 59462, France

Location

Office-based Specialist in vascular medecine

Longwy, 54440, France

Location

Edouard Herriot Hospital

Lyon, 69003, France

Location

Office-based Specialist in vascular medecine

Lyon, 69007, France

Location

Office-based Specialist in vascular medecine

Malemort-sur-Corrèze, 19360, France

Location

Office-based Specialist in vascular medecine

Maubeuge, 59600, France

Location

Hospital of Belfort

Montbéliard, 25200, France

Location

Office-based Specialist in vascular medecine

Montélimar, 26200, France

Location

Office-based Specialist in vascular medecine

Montluçon, 03100, France

Location

University hospital Montpellier

Montpellier, 34295, France

Location

Office-based Specialist in vascular medecine

Mulhouse, 68200, France

Location

Office-based Specialist in vascular medecine

Nice, 06000, France

Location

Office-based Specialist in vascular medecine

Niort, 79000, France

Location

Office-based Specialist in vascular medecine

Noumea, 98895, France

Location

Hospital Center

Orléans, 45000, France

Location

Office-based Specialist in vascular medecine

Orléans, 45100, France

Location

Hospital center Territorial Mamao

Papeete, 98713, France

Location

Office-based Specialist in vascular medecine

Paris, 75116, France

Location

Office-based Specialist in vascular medecine

Perpignan, 66000, France

Location

Hospital Center

Périgueux, 24000, France

Location

Office-based Specialist in vascular medecine

Péronne, 80200, France

Location

Office-based Specialist in vascular medecine

Pontcharra, 38530, France

Location

Office-based Specialist in vascular medecine

Pornic, 44210, France

Location

Office-based Specialist in vascular medecine

Puilboreau, 17138, France

Location

Office-based Specialist in vascular medecine

Rambouillet, 78120, France

Location

Office-based Specialist in vascular medecine

Rochefort, 17300, France

Location

Office-based Specialist in vascular medecine

Rodez, 12000, France

Location

Hospital center Rodez

Rodez, 12027, France

Location

Office-based Specialist in vascular medecine

Rouen, 76100, France

Location

Office-based Specialist in vascular medecine

Saint-Aubin-de-Médoc, 33160, France

Location

Office-based Specialist in vascular medecine

Saint-Aubin-sur-Scie, 76550, France

Location

Office-based Specialist in vascular medecine

Saint-Benoît, 86280, France

Location

Office-based Specialist in vascular medecine

Saint-Etienne, 42000, France

Location

University Hospital Saint Etienne

Saint-Etienne, 42100, France

Location

Memorial Hospital

Saint-Lô, 50000, France

Location

Office-based Specialist in vascular medecine

Saint-Lô, 50000, France

Location

Office-based Specialist in vascular medecine

Saint-Priest, 69800, France

Location

Hospital

Saint-Quentin, 02100, France

Location

Office-based Specialist in vascular medecine

Sallanches, 74700, France

Location

Office-based Specialist in vascular medecine

Sarcelles, 95200, France

Location

Office-based Specialist in vascular medecine

Sarrebourg, 57400, France

Location

Office-based Specialist in vascular medecine

Sarreguemines, 57200, France

Location

Office-based Specialist in vascular medecine

Savigny-sur-Orge, 91600, France

Location

Office-based Specialist in vascular medecine

Sélestat, 67600, France

Location

Office-based Specialist in vascular medecine

Strasbourg, 67000, France

Location

Office-based Specialist in vascular medecine

Toulon, 83000, France

Location

University Hospital Rangueil

Toulouse, 31059, France

Location

Office-based Specialist in vascular medecine

Toulouse, 31076, France

Location

Office-based Specialist in vascular medecine

Tours, 37000, France

Location

Office-based Specialist in vascular medecine

Trélazé, 49800, France

Location

Office-based Specialist in vascular medecine

Trois-Rivières (Guadeloupe), 97114, France

Location

Office-based Specialist in vascular medecine

Vannes, 56000, France

Location

Office-based Specialist in vascular medecine

Versailles, 78000, France

Location

Office-based Specialist in vascular medecine

Vienne, 38200, France

Location

Office-based Specialist in vascular medecine

Villeurbanne, 69100, France

Location

Office-based Specialist in vascular medecine

Vincennes, 94300, France

Location

Office-based Specialist in vascular medecine

Vizille, 38220, France

Location

Office-based Specialist in vascular medecine

Voiron, 38500, France

Location

Office-based Specialist in vascular medecine

Wissembourg, 67160, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Carotid Stenosis; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aortic Aneurysm; Aneurysm; Aortic Diseases

Study Officials

• Patrick CARPENTIER, Professor

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: October 20, 2010
• Study Start: January 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

FR (114); BE (1)