Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success...
-
Upload
hayden-corin -
Category
Documents
-
view
213 -
download
0
Transcript of Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success...
![Page 1: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/1.jpg)
Optical Coherence TomographyAssessment of gender diVersityin primary Angioplasty
Plan for SuccessGISE Congress, Genova, 17 Oct. 2010
![Page 2: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/2.jpg)
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
2
![Page 3: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/3.jpg)
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
3
![Page 4: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/4.jpg)
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
![Page 5: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/5.jpg)
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
5
![Page 6: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/6.jpg)
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
6
![Page 7: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/7.jpg)
Int’l Scientific Board
7
Ghada Mikhail
Elena Ladich
Renu Virmani
Marco Costa Chen Yundai Takashi Akasaka
![Page 8: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/8.jpg)
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
8
Enrollment10 months
![Page 9: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/9.jpg)
Methodology
QCA, OCT and histological thrombus analysis• Shed light on the underlying mechanisms of
coronary thrombosis in women
• International core labs, blinded analysis
9
![Page 10: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/10.jpg)
Total study duration: 2.5 years
Timelines
10
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
![Page 11: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/11.jpg)
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
![Page 12: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/12.jpg)
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
![Page 13: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/13.jpg)
CatchTrialSecure data tracking with CatchTrial• High-speed web-based transfer of OCT raw data• Automated, real time study analyses-reports
13
MEDITRIAL for OCTAVIA
![Page 14: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/14.jpg)
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
14
![Page 15: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/15.jpg)
Real-time Study Progress
15
![Page 16: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/16.jpg)
Easy Safety Tracking
16
![Page 17: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/17.jpg)
Rapid Endpoint Assessment
17
![Page 18: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/18.jpg)
Catchtrial for Octavia• Creation of tables replicating published articles• Real-time results as data are entered by sites
18
![Page 19: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/19.jpg)
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
19
MEDITRIAL for OCTAVIA
![Page 20: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/20.jpg)
Support for Investigators
20
MEDITRIAL for OCTAVIA
![Page 21: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/21.jpg)
RossellaClinical
AlessioSoftware
MonicaScientific
Rob Communication
BarbaraLogistics
Behind the Scenes
21
MEDITRIAL for OCTAVIA
![Page 22: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/22.jpg)
Contacts
22
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]
![Page 23: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/23.jpg)
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
23
![Page 24: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/24.jpg)
24
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
![Page 25: Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty Plan for Success GISE Congress, Genova, 17 Oct. 2010.](https://reader035.fdocuments.us/reader035/viewer/2022062621/551c2c8d550346a84f8b6147/html5/thumbnails/25.jpg)
Thank you
25