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Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.

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Presentation on theme: "Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010."— Presentation transcript:

1 Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010

2 Today’s Presentation The objective, methodologies and technological tools of the OCTAVIA trial represent an innovation for Italian and international research Today we will discuss the study’s: Background & Motivation Team & Methodology Objectives & Timelines Technology & Communication 2

3 About OCTAVIA OCTAVIA will help resolve important unanswered questions that lead to better care for women with coronary heart disease AND is also unique because…  First national cooperation of leading OCT centers  New model for rapid web-based image transfer  Emphasis on real-time results  Dedicated communication tools 3

4 Meet the OCTAVIA Team Scientific promoter The Italian Society of Interventional Cardiology (GISE) Study coordinator Dr. Giulio Guagliumi, recognized worldwide as an opinion leader for coronary OCT Study centers Fifteen OCT centers across Italy 4

5 OCTAVIA Study Centers G. Guagliumi Centro Coordinatore M. Valgimigli G. Trani C. Pierli B. Reimers R. Garbo G. Sangiorgi D. Capodanno G. Tarantino U. Limbruni M. De Benedicts F. Saia L. Vignali S. Marra G. Tuminello 5

6 Italian Steering Committee D. Trabattoni M. Valgimigli G. TraniF. Saia D. Capodanno L. De Luca G. Biondi Zoccai O. Manfrini B. Castiglioni Steering committee Safety monitoring board Medical reviewer Statistical reviewer 6

7 Int’l Scientific Board 7 Ghada Mikhail Elena Ladich Renu Virmani Marco Costa Chen YundaiTakashi Akasaka

8 Protocol Overview Patients 140 STEMI patients  6 hrs – 70 women – 70 age-matched men Procedures Primary PCI with OCT pre and post OCT at 9 months Follow-up 12 months Data Fully electronic CRF and image management International core labs 8 Enrollment 10 months

9 Methodology QCA, OCT and histological thrombus analysis Shed light on the underlying mechanisms of coronary thrombosis in women International core labs, blinded analysis 9

10 Total study duration: 2.5 years Timelines 10 Planning EC Submissions Startup Study Initiation Recruitment Completion of Follow-up Closeout Final Report Oct–Nov 2010Dec 2010Jan–Sept 2011Dec 2012Feb–Apr 2013 = Startup = Active Study = Completion

11 Research Organization More trial, less error. OCTAVIA is overseen by Meditrial, a contract research organization specializing in device trials. We offer expertise and advanced technology, all within a streamlined model that seeks to eliminate wasted time and resources. 11

12 Complete Management 1.Strategic program 2.CatchTrial: data collection/analysis and electronic images 3.Startup, management, monitoring 4.Communication: logo, website, newsletter 12 MEDITRIAL for OCTAVIA

13 CatchTrial Secure data tracking with CatchTrial High-speed web-based transfer of OCT raw data Automated, real time study analyses-reports 13 MEDITRIAL for OCTAVIA

14 CatchTrial IMAGES Speed Maximal speed with proprietary software for rapid upload/download. Upload speed: raw OCT data in min* Download speed: 5 min* You can normally use the PC during image transfer. * Standard ADSL connection 14

15 Real-time Study Progress 15

16 Easy Safety Tracking 16

17 Rapid Endpoint Assessment 17

18 Catchtrial for Octavia Creation of tables replicating published articles Real-time results as data are entered by sites 18

19 Strategia per approvazione rapida Selezione centri Selezione CRO team Pianificazione-budget Conformità con - Normative - Procedure del centro Sottomissioni complete ed accurate Stretto contatto con i centri Gestione per Reclutamento veloce Controllo dati Verifica dei risultati 4°step STARTUP e GESTIONE 4°step STARTUP e GESTIONE 3°step APPROVAZIONE RAPIDA 3°step APPROVAZIONE RAPIDA 2°step DOSSIER DELLO STUDIO 2°step DOSSIER DELLO STUDIO 1°step STRATEGIA 1°step STRATEGIA Step by Step 19 MEDITRIAL for OCTAVIA

20 Support for Investigators 20 MEDITRIAL for OCTAVIA

21 Rossella Clinical Alessio Software Monica Scientific Rob Communication Barbara Logistics Behind the Scenes 21 MEDITRIAL for OCTAVIA

22 Contacts 22 Meditrial Srl Via Savoia 78, Roma Tel – Fax Monica Tocchi Cell Rossella Mercuri Cell Barbara Pesce Cell Rob Meyerson Skype rob.meyerson Alessio Ricciutelli

23 In Summary This important study represents an opportunity for the Italian interventional community to set a new model of collaboration, quality and efficiency The main challenges ahead are the approval process and patient recruitment Next step: collaboration for quick approval TARGET STUDY STARTUP: January

24 24 EC submission plan CenterEC DeadlineCenterEC Deadline S. Giovanni TO1 Nov.Parma12 Nov. Bologna2-4 Nov.Padova13 Nov. Gemelli RM4 Nov.Siena15 Nov. Mirano VE4 Nov.Mauriziano TO20 Nov. Modena4 Nov.Molinette TO25 Nov. Ferrara5 Nov.Asti26 Nov. Ferrarotto CT6 Nov.Grosseto30 Nov. BERGAMO20 October

25 Thank you 25


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