Vascular DiseasesOPTIMEVNCT00670540
Epidemiology of Thromboembolism Disease: A Cohort Study
An observational study of Vascular Diseases and Embolism and Thrombosis, run by University Hospital, Grenoble at 231 sites in 3 countries.
Trial summary
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied 1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Embolism and Thrombosis, Phlebitis
- What is being tested?
- procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis
- How many people
- 8,256 participants
- Where
- 231 sitesin 3 countries
- Study dates
- Nov 2004to Feb 2010
- Phase
- Observational
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: All male or female inpatients and outpatients hospital and office-based. 18 years old with clinical suspicion of deep vein thrombosis (DVT) or pulmonary embolism (PE). Patients with cognitive disorders or language impairment preventing collection of risk factor data by history-taking were excluded.
Who may be able to join
- patient aged more than 18
- male or female
- patients with clinical thromboembolic signs (deep vein thrombosis or pulmonary embolism)
Who cannot join
- patient less than 18 years old
- patient unable to understand
- patient who refused to participate
Trial locations and contacts
231 sites in 3 countries.
231 sites in 3 countries
France229 sites
General Hospital
Abbeville
Office-based Specialist in vascular medecine
Albertville, 73200
Office-based Specialist in vascular medecine
Albi, 81000
Office-based Specialist in vascular medecine
Alençon, 61000
Office-based Specialist in vascular medecine
Alès, 30100
Office-based Specialist in vascular medecine
Ambares, 33440
Office-based Specialist in vascular medecine
Amberieu En Buget, 01500
Office-based Specialist in vascular medecine
Amiens, 80000
University Hospital
Amiens
Office-based Specialist in vascular medecine
Ancenis, 44150
Office-based Specialist in vascular medecine
Angers, 49000
University Hospital
Angers
Office-based Specialist in vascular medecine
Annecy, 74000
Hospital
Annecy
Hospital
Armentières
Office-based Specialist in vascular medecine
Arnouville, 95400
Office-based Specialist in vascular medecine
Arpajon, 91290
Office-based Specialist in vascular medecine
Arras, 62000
Office-based Specialist in vascular medecine
Aubenas, 07200
Hospital
Auch
Office-based Specialist in vascular medecine
Auxerre, 89000
Office-based Specialist in vascular medecine
Bagnoles-de-l'orme, 61140
Office-based Specialist in vascular medecine
Beauvais, 60000
University Hospital
Belfort
Office-based Specialist in vascular medecine
Bergerac, 24100
Office-based Specialist in vascular medecine
Besançon, 25000
Office-based Specialist in vascular medecine
Béziers, 35500
Office-based Specialist in vascular medecine
Blagnac, 31700
Office-based Specialist in vascular medecine
Bordeaux, 33000
Hospital St ANDRE
Bordeaux
Office-based Specialist in vascular medecine
Boulogne-sur-Mer, 62200
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 La Cavale Blanche
Brest
Office-based Specialist in vascular medecine
Bretenoux, 46130
Office-based Specialist in vascular medecine
Brétigny-sur-Orge, 91220
Office-based Specialist in vascular medecine
Bron, 69500
Office-based Specialist in vascular medecine
Cabestany, 66330
University Hospital
Caen
Office-based Specialist in vascular medecine
Caluire-et-Cuire, 69300
Office-based Specialist in vascular medecine
Cambrai, 59400
Office-based Specialist in vascular medecine
Cannes, 06400
Office-based Specialist in vascular medecine
Carcassonne, 11000
Hospital Antoine Gayraud
Carcassonne
Office-based Specialist in vascular medecine
Castanet-Tolosan, 31320
Office-based Specialist in vascular medecine
Castres, 81100
Office-based Specialist in vascular medecine
Cenon, 33150
Office-based Specialist in vascular medecine
Chalon En Champagne, 51000
Office-based Specialist in vascular medecine
Chalon-sur-Saône, 71100
Office-based Specialist in vascular medecine
Chambéry, 73000
Hospital
Chambéry
Office-based Specialist in vascular medecine
Champagnole, 39300
Office-based Specialist in vascular medecine
Chantilly, 60500
Office-based Specialist in vascular medecine
Charleville-Mézières, 08000
Office-based Specialist in vascular medecine
Chartres, 28000
Office-based Specialist in vascular medecine
Châteaubriant, 44110
Office-based Specialist in vascular medecine
Cholet, 49300
Office-based Specialist in vascular medecine
Clamart, 92140
Office-based Specialist in vascular medecine
Clapiers, 34830
Office-based Specialist in vascular medecine
Clermont-Ferrand, 63000
Hospital Hotel Dieu
Clermont-Ferrand
Office-based Specialist in vascular medecine
Clermont-l'Hérault, 34800
Office-based Specialist in vascular medecine
Clisson, 44190
Office-based Specialist in vascular medecine
Cluses, 74300
Office-based Specialist in vascular medecine
Colomiers, 31770
General Hospital
Compiègne
Office-based Specialist in vascular medecine
Coulommiers, 77120
Office-based Specialist in vascular medecine
Crolles, 38920
Office-based Specialist in vascular medecine
Denain, 59220
Office-based Specialist in vascular medecine
Dieppe, 76200
Office-based Specialist in vascular medecine
Dijon, 21000
Hospital Bocage
Dijon
University Hospital
Dijon
Office-based Specialist in vascular medecine
Draguignan, 83300
Office-based Specialist in vascular medecine
Échirolles, 38130
Office-based Specialist in vascular medecine
Ermont, 95120
Office-based Specialist in vascular medecine
Évreux, 27000
Office-based Specialist in vascular medecine
Fécamp, 76400
Office-based Specialist in vascular medecine
Feytiat, 87220
Office-based Specialist in vascular medecine
Figeac, 46100
Hospital
Flers
Office-based Specialist in vascular medecine
Foix, 09000
Hospital Val d'Ariege
Foix
Office-based Specialist in vascular medecine
Fontenay-le-Comte, 85200
Office-based Specialist in vascular medecine
Glanes, 46130
Office-based Specialist in vascular medecine
Grenoble, 38000
University Hospital Grenoble
Grenoble, 38043
Office-based Specialist in vascular medecine
Gruchet-le-Valasse, 76210
Office-based Specialist in vascular medecine
Hœnheim, 67800
Office-based Specialist in vascular medecine
Issy-les-Moulineaux, 92130
Office-based Specialist in vascular medecine
Istres, 13800
Office-based Specialist in vascular medecine
L'Île-Rousse, 20220
Office-based Specialist in vascular medecine
La Roche-sur-Yon, 85000
Departemental Hospital
La Roche-sur-Yon
Office-based Specialist in vascular medecine
La Rochelle, 17000
Office-based Specialist in vascular medecine
Lannion, 22300
Office-based Specialist in vascular medecine
Lattes, 34970
Office-based Specialist in vascular medecine
Laval, 53000
Office-based Specialist in vascular medecine
Laxou, 54520
Hospital Versailles
Le Chesnay
Office-based Specialist in vascular medecine
Le Mans, 72000
Office-based Specialist in vascular medecine
Le Quesnoy, 59530
Office-based Specialist in vascular medecine
Levallois-Perret, 92300
Office-based Specialist in vascular medecine
Limoges, 87000
Office-based Specialist in vascular medecine
Lisieux, 14100
Hospital Saint Philibert
Lomme
Office-based Specialist in vascular medecine
Longjumeau, 91160
Office-based Specialist in vascular medecine
Longwy, 54440
Office-based Specialist in vascular medecine
Lons-le-Saunier, 39000
Office-based Specialist in vascular medecine
Lorient, 56100
Office-based Specialist in vascular medecine
Louviers, 27400
Hospital Edouard Herriot
Lyon
University Hospital
Lyon
Office-based Specialist in vascular medecine
Malemort-sur-Corrèze, 19360
Office-based Specialist in vascular medecine
Manosque, 04100
Office-based Specialist in vascular medecine
Mantes-la-Jolie, 78200
Office-based Specialist in vascular medecine
Marcq-en-Barœul, 59700
Office-based Specialist in vascular medecine
Marseille, 13000
Office-based Specialist in vascular medecine
Martinique, 97000
Office-based Specialist in vascular medecine
Maurepas, 78310
Office-based Specialist in vascular medecine
Meaux, 77100
Office-based Specialist in vascular medecine
Metz, 57000
Office-based Specialist in vascular medecine
Meudon, 92190
Office-based Specialist in vascular medecine
Moissac, 82200
Office-based Specialist in vascular medecine
Montaigu, 85600
Office-based Specialist in vascular medecine
Montbéliard, 25200
General Hospital
Montbéliard
Hospital Jacques Monod
Montivilliers
Office-based Specialist in vascular medecine
Montluçon, 03100
Hospital
Montluçon
Hospital
Montmorillon
Office-based Specialist in vascular medecine
Montpellier, 34000
Hospital St Eloi
Montpellier
Office-based Specialist in vascular medecine
Mulhouse, 68100
Office-based Specialist in vascular medecine
Nancy, 54000
Office-based Specialist in vascular medecine
Nantes, 44000
Office-based Specialist in vascular medecine
Narbonne, 11100
Office-based Specialist in vascular medecine
Nice, 06000
Office-based Specialist in vascular medecine
Nîmes, 30000
Office-based Specialist in vascular medecine
Niort, 79000
Office-based Specialist in vascular medecine
Noumea (Nouvelle Calédonie), 98800
Office-based Specialist in vascular medecine
Noyal-Pontivy, 56920
Office-based Specialist in vascular medecine
Noyon, 60400
Office-based Specialist in vascular medecine
Orange, 84100
Office-based Specialist in vascular medecine
Orléans, 45000
Regional Hospital
Orleans La Source
Office-based Specialist in vascular medecine
Paris, 75000
Hospital Croix Saint Simon
Paris
Hospital
Périgueux
Office-based Specialist in vascular medecine
Péronne, 80200
Office-based Specialist in vascular medecine
Pessac, 33600
Office-based Specialist in vascular medecine
Poissy, 78300
Office-based Specialist in vascular medecine
Poitiers, 86000
Office-based Specialist in vascular medecine
Pontarlier, 25300
Office-based Specialist in vascular medecine
Pornic, 44210
Office-based Specialist in vascular medecine
Puilboreau, 17000
Office-based Specialist in vascular medecine
Quimper, 29000
Office-based Specialist in vascular medecine
Rambouillet, 78120
Office-based Specialist in vascular medecine
Redon, 35600
Office-based Specialist in vascular medecine
Reims, 51200
University Hospital
Reims
Office-based Specialist in vascular medecine
Riom, 63200
Office-based Specialist in vascular medecine
Rivesaltes, 66600
Office-based Specialist in vascular medecine
Rochefort, 17300
Office-based Specialist in vascular medecine
Rodez, 12000
Hospital
Rodez, MD
Office-based Specialist in vascular medecine
Romans-sur-Isère, 26000
Office-based Specialist in vascular medecine
Rouen, 76000
Office-based Specialist in vascular medecine
Sablé-sur-Sarthe, 72300
Office-based Specialist in vascular medecine
Saint Genevieve Des Bois, 91700
Cmc Les Petites Roches
Saint Hilaire Du Touvert
Office-based Specialist in vascular medecine
Saint Pierre (ile de La Reunion), 97410
Office-based Specialist in vascular medecine
Saint-Aubin-de-Médoc, 33160
Office-based Specialist in vascular medecine
Saint-Benoît, 86200
Office-based Specialist in vascular medecine
Saint-Brieuc, 22000
Office-based Specialist in vascular medecine
Saint-Chamond, 42400
Office-based Specialist in vascular medecine
Saint-Cloud, 92210
Office-based Specialist in vascular medecine
Saint-Cyr-l'École, 78210
Office-based Specialist in vascular medecine
Saint-Égrève, 38120
Office-based Specialist in vascular medecine
Saint-Etienne, 42000
University Hospital
Saint-Etienne
Office-based Specialist in vascular medecine
Saint-Gaudens, 31800
Office-based Specialist in vascular medecine
Saint-Germain-en-Laye, 78100
Office-based Specialist in vascular medecine
Saint-Lô, 50000
Memorial Hospital
Saint-Lô
Office-based Specialist in vascular medecine
Saint-Martin-Boulogne, 62280
Office-based Specialist in vascular medecine
Saint-Priest, 69800
Hospital
Saint-Quentin
Office-based Specialist in vascular medecine
Sallanches, 74700
Office-based Specialist in vascular medecine
Salon-de-Provence, 13300
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
Saverne, 67700
Office-based Specialist in vascular medecine
Savigny-sur-Orge, 91600
Office-based Specialist in vascular medecine
Sceaux, 92330
Office-based Specialist in vascular medecine
Sélestat, 67600
Office-based Specialist in vascular medecine
Sèvres, 92310
Office-based Specialist in vascular medecine
Strasbourg, 67000
Regional University Hospital
Strasbourg
Office-based Specialist in vascular medecine
Talant, 21000
Office-based Specialist in vascular medecine
Tarare, 69170
Office-based Specialist in vascular medecine
Toulouse, 31000
University Hospital Rangueil Larrey
Toulouse
University Hospital Rangueil
Toulouse
University Hospital
Toulouse
Office-based Specialist in vascular medecine
Tours, 37000
Office-based Specialist in vascular medecine
Trois Rivieres (guadeloupe), 97114
Office-based Specialist in vascular medecine
Troyes, 10000
Office-based Specialist in vascular medecine
Valence, 26000
Office-based Specialist in vascular medecine
Vannes, 56000
Office-based Specialist in vascular medecine
Vendôme, 41100
Office-based Specialist in vascular medecine
Vénissieux, 69200
Office-based Specialist in vascular medecine
Verrières-le-Buisson, 91370
Office-based Specialist in vascular medecine
Versailles, 78000
Office-based Specialist in vascular medecine
Vesoul, 70000
Office-based Specialist in vascular medecine
Vichy, 03200
Office-based Specialist in vascular medecine
Vienne, 38200
Office-based Specialist in vascular medecine
Villebon-sur-Yvette, 91140
Office-based Specialist in vascular medecine
Villefranche-sur-Saône, 69400
Office-based Specialist in vascular medecine
Villemoisson-sur-Orge, 91360
Office-based Specialist in vascular medecine
Villeurbanne, 69100
Office-based Specialist in vascular medecine
Vincennes, 94300
Office-based Specialist in vascular medecine
Viroflay, 78220
Office-based Specialist in vascular medecine
Vizille, 38220
Office-based Specialist in vascular medecine
Voiron, 38500
Office-based Specialist in vascular medecine
Wissembourg, 67160
Office-based Specialist in vascular medecine
Wizernes, 62570
Guadeloupe1 site
Office-based Specialist in vascular medecine
Basse-Terre, 97100
About this study
Official title: A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied
- do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
- Is it necessary to obtain a detailed history of thromboembolic disease ?
- Do older patients have particular risk factors ?
- Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
- Do predictive clinical scores have the same performance for both in and outpatients ?
- Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
- The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.
Read the detailed description
The OPTIMEV study is a prospective epidemiological multicenter cohort study, including in-and outpatients clinically suspected of thromboembolic disease. Deep vein thrombosis is diagnosed using a duplex ultrasound examination, whereas pulmonary embolism is investigated by lung scan scintigraphy or computed helical tomodensitometry and/or duplex ultrasound examination. Initial data on medical history, clinical symptoms, presence of transient and chronic risk factors, diagnosis at the end of the medical examination, diagnostic tests results, treatment (type and duration) are collected by the physician into an electronic medical record. Other general medical considerations are collected (particularly on cardiovascular diseases). A phone follow up at 3 months, 1, 2 and 3 years is realised by the Centre for Clinical Research of Grenoble. All Venous ThromboEmbolism (VTE) positive patients (including superficial vein thrombosis) are contacted. For each VTE positive a negative one is selected (same site, same season). Data on mortality, development or recurrence of VTE, treatments prescribed (type + duration), major bleeding, cancer onset, cardiovascular events and venous insufficiency (leg ulcer) are collected. All these serious adverse events are documented and reviewed by an independent critical events committee.
- Conditions
- Vascular Diseases, Embolism and Thrombosis, Phlebitis, Venous Insufficiency, Pulmonary Embolism
- Being tested
- procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis
- Keywords
- pulmonary embolism, duplex ultrasound examination, recurrence
- Medical subject headings
- Vascular Diseases, Embolism and Thrombosis, Phlebitis, Venous Insufficiency, Pulmonary Embolism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosisOther
Also called VTE (venous thromboembolism), DVT (deep vein thrombosis), PE (pulmonary embolism)
patients with a clinical suspicion of Venous ThromboEmbolism (VTE = Deep Vein Thrombosis or Pulmonary Embolism) were eligible
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with suspected Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) Receives: Other: procedure of Deep Vein Thrombosis (DVT) and PE (Pulmonary Embolism) diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Developed a New or Recurrence of Venous Thromboembolism (VTE)
new VTE which can occur during follow up for no VTE patients at inclusion. Or VTE recurrence for VTE patients at inclusion.
Measured: at 3 years
Secondary outcomes (6)
Percentage of Participants Who Developed Major Bleeding Events
Measured: at 3 years
Percentage of Participants With Treatment Anticoagulant Prescribed
Measured: after inclusion
Percentage of Participants Who Developed Cardiovascular Events
Measured: at 3 years
Percentage of Participants Who Died From Any Cause
Measured: at 3 years
Percentage of Participants Who Developed Cancer Onset
Measured: at 3 years
Percentage of Participants Who Developed Venous Insufficiency (Leg Ulcer)
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startNov 2004
- Primary completionJan 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- 8,256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Ministry of Health, France, SFMV (Société Française de Médecine Vasculaire)
- Responsible party
- Sponsor
- Investigators
- Jean Luc JB BOSSON, MD, Principal investigator, University Hospital, GrenobleMarie Antoinette SEVESTRE, MD, Study chair, Amiens University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670540
- Sponsor's protocol ID
- DCIC-04-02
- Acronym
- OPTIMEV
- Status last verified
- May 2012
- First submitted
- 30 Apr 2008
- Last updated
- 8 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.
PubMed 14638561Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20. doi: 10.1001/archinte.160.22.3415.
PubMed 11112234Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5.
PubMed 10227218Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9. doi: 10.1001/archinte.163.10.1213.
PubMed 12767959Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quere I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. doi: 10.1016/s0398-0499(05)88206-x. French.
PubMed 16292199Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quere I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.
PubMed 25104514Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.
PubMed 25087889Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.
PubMed 22429908Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quere I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.
PubMed 20630688