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Plan for Success GISE Congress, Genova, 17 Oct
Plan for Success GISE Congress, Genova, 17 Oct
Today’s Presentation
Today’s Presentation
About OCTAVIA
About OCTAVIA
Meet the OCTAVIA Team
Meet the OCTAVIA Team
OCTAVIA Study Centers
OCTAVIA Study Centers
Italian Steering Committee
Italian Steering Committee
Int’l Scientific Board
Int’l Scientific Board
Protocol Overview
Protocol Overview
Methodology
Methodology
Timelines
Timelines
Research Organization
Research Organization
Complete Management
Complete Management
CatchTrial
CatchTrial
CatchTrial IMAGES Speed
CatchTrial IMAGES Speed
Real-time Study Progress
Real-time Study Progress
Easy Safety Tracking
Easy Safety Tracking
Rapid Endpoint Assessment
Rapid Endpoint Assessment
Catchtrial for Octavia
Catchtrial for Octavia
Step by Step
Step by Step
Support for Investigators
Support for Investigators
Behind the Scenes
Behind the Scenes
Contacts
Contacts
In Summary
In Summary
EC submission plan
EC submission plan
Thank you
Thank you

Презентация: «Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty». Автор: monica. Файл: «Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty.ppt». Размер zip-архива: 4171 КБ.

Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty

содержание презентации «Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty.ppt»
СлайдТекст
1 Plan for Success GISE Congress, Genova, 17 Oct

Plan for Success GISE Congress, Genova, 17 Oct

2010

Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty

2 Today’s Presentation

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

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

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

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

5

6 Italian Steering Committee

Italian Steering Committee

B. Castiglioni

D. Trabattoni

G. Biondi Zoccai

M. Valgimigli

G. Trani

F. Saia

L. De Luca

O. Manfrini

D. Capodanno

6

7 Int’l Scientific Board

Int’l Scientific Board

Chen Yundai

Takashi Akasaka

Ghada Mikhail

Marco Costa

Elena Ladich

Renu Virmani

7

8 Protocol Overview

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

8

9 Methodology

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 Timelines

Timelines

Total study duration: 2.5 years

Oct–Nov 2010

Dec 2010

Jan–Sept 2011

Dec 2012

Feb–Apr 2013

Planning EC Submissions

Startup Study Initiation

Recruitment

Completion of Follow-up

Closeout Final Report

= Startup

= Active Study

= Completion

10

11 Research Organization

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

Complete Management

MEDITRIAL for OCTAVIA

Strategic program CatchTrial: data collection/analysis and electronic images Startup, management, monitoring Communication: logo, website, newsletter

12

13 CatchTrial

CatchTrial

MEDITRIAL for OCTAVIA

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

13

14 CatchTrial IMAGES Speed

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

15 Real-time Study Progress

Real-time Study Progress

15

16 Easy Safety Tracking

Easy Safety Tracking

16

17 Rapid Endpoint Assessment

Rapid Endpoint Assessment

17

18 Catchtrial for Octavia

Catchtrial for Octavia

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

18

19 Step by Step

Step by Step

MEDITRIAL for OCTAVIA

4°step STARTUP e GESTIONE

3°step APPROVAZIONE RAPIDA

2°step DOSSIER DELLO STUDIO

1°step STRATEGIA

19

20 Support for Investigators

Support for Investigators

MEDITRIAL for OCTAVIA

20

21 Behind the Scenes

Behind the Scenes

MEDITRIAL for OCTAVIA

Monica Scientific

Barbara Logistics

Rossella Clinical

Rob Communication

Alessio Software

21

22 Contacts

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

22

23 In Summary

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

24 EC submission plan

EC submission plan

Center

EC Deadline

Center

EC Deadline

BERGAMO

20 October

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.

24

25 Thank you

Thank you

25

«Optical Coherence Tomography Assessment of gender diVersity in primary Angioplasty»
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