Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty
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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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Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty. Plan for Success GISE Congress, Genova, 17 Oct. 2010. Today’s Presentation. - PowerPoint PPT Presentation
Transcript of Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty
Optical Coherence TomographyAssessment of gender diVersityin primary Angioplasty
Plan for SuccessGISE Congress, Genova, 17 Oct. 2010
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 & MotivationTeam & MethodologyObjectives & TimelinesTechnology & Communication
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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 centersNew model for rapid web-based image transferEmphasis on real-time resultsDedicated communication tools
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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
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OCTAVIA Study Centers
G. GuagliumiCentro 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
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Italian Steering Committee
D. Trabattoni
M. Valgimigli
G. Trani
F. Saia
D. Capodanno
L. De Luca
G. Biondi Zoccai
O. Manfrini
B. Castiglioni
Steering committeeSafety monitoring boardMedical reviewerStatistical reviewer
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Int’l Scientific Board
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Ghada Mikhail
Elena Ladich
Renu Virmani
Marco Costa Chen Yundai Takashi Akasaka
Protocol OverviewPatients
140 STEMI patients 6 hrs– 70 women– 70 age-matched men
ProceduresPrimary PCI with OCT pre and postOCT at 9 monthsFollow-up 12 months
DataFully electronic CRF and image managementInternational core labs
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Enrollment10 months
Methodology
QCA, OCT and histological thrombus analysis• Shed light on the underlying mechanisms of
coronary thrombosis in women
• International core labs, blinded analysis
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Total study duration: 2.5 years
Timelines
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Planning EC Submissions
Startup Study Initiation
RecruitmentCompletion of
Follow-upCloseout Final
Report
Oct–Nov 2010 Dec 2010 Jan–Sept 2011 Dec 2012 Feb–Apr 2013
= Startup
= Active Study
= Completion
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.
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Complete Management
1. Strategic program
2. CatchTrial: data collection/analysis and electronic images
3. Startup, management, monitoring
4. Communication: logo, website, newsletter
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MEDITRIAL for OCTAVIA
CatchTrialSecure data tracking with CatchTrial• High-speed web-based transfer of OCT raw data• Automated, real time study analyses-reports
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MEDITRIAL for OCTAVIA
CatchTrial IMAGES Speed
Maximal speed with proprietary 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
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Real-time Study Progress
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Easy Safety Tracking
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Rapid Endpoint Assessment
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Catchtrial for Octavia• Creation of tables replicating published articles• Real-time results as data are entered by sites
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4°stepSTARTUP e GESTIONE
4°stepSTARTUP e GESTIONE3°step
APPROVAZIONE RAPIDA 3°step
APPROVAZIONE RAPIDA
2°stepDOSSIER DELLO STUDIO
2°stepDOSSIER DELLO STUDIO
1°stepSTRATEGIA
1°stepSTRATEGIA
Step by Step
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MEDITRIAL for OCTAVIA
Support for Investigators
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MEDITRIAL for OCTAVIA
RossellaClinical
AlessioSoftware
MonicaScientific
Rob Communication
BarbaraLogistics
Behind the Scenes
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MEDITRIAL for OCTAVIA
Contacts
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Meditrial SrlVia Savoia 78, 00198 RomaTel. 06 45429780 – Fax 06 4542.9781
Monica [email protected]. 393.1155344
Rossella [email protected]. 335.6130262
Barbara [email protected]. 345.1500146
Rob [email protected] rob.meyerson
Alessio [email protected]
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
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EC submission plan
Center EC Deadline Center EC Deadline
S. Giovanni TO 1 Nov. Parma 12 Nov.
Bologna 2-4 Nov. Padova 13 Nov.
Gemelli RM 4 Nov. Siena 15 Nov.
Mirano VE 4 Nov. Mauriziano TO 20 Nov.
Modena 4 Nov. Molinette TO 25 Nov.
Ferrara 5 Nov. Asti 26 Nov.
Ferrarotto CT 6 Nov. Grosseto 30 Nov.
BERGAMO 20 October
Thank you
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