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Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty

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

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Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty

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  1. Optical Coherence TomographyAssessment of gender diVersityin 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

  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

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

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

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

  7. Int’l Scientific Board ChenYundai Takashi Akasaka GhadaMikhail Marco Costa Elena Ladich Renu Virmani

  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 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

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

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

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

  14. CatchTrial IMAGES Speed Maximal speed withproprietary software for rapid upload/download. Upload speed: raw OCT data in 30-60 min* Download speed: 5 min* You can normally use the PC during image transfer. * Standard ADSL connection

  15. Real-time Study Progress

  16. Easy Safety Tracking

  17. Rapid Endpoint Assessment

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

  19. MEDITRIAL for OCTAVIA Step by Step 4°step STARTUP e GESTIONE 3°step APPROVAZIONE RAPIDA 2°step DOSSIER DELLO STUDIO 1°step STRATEGIA

  20. MEDITRIAL for OCTAVIA Support for Investigators Informed Consent Process Qualification of PI/Site Compliance with Protocol Communi-cationwith the Ethics Committee Medical Care of Subjects / Safety Reporting

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

  22. Contacts Meditrial Srl Via Savoia 78, 00198 Roma Tel. 06 45429780 – Fax 06 4542.9781 Barbara Pesce b.pesce@meditrial.eu Cell. 345.1500146 Rob Meyerson r.meyerson@meditrialeurope.com Skype rob.meyerson Monica Tocchi m.tocchi@meditrial.eu Cell. 393.1155344 Alessio Ricciutelli helpdesk@catchtrial.com Rossella Mercuri r.mercuri@meditrial.eu Cell. 335.6130262

  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 2011

  24. EC submission plan

  25. Thank you

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