Registro GIMSI

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Simone Landi
10 anni fa
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1 Registro GIMSI

2 Registro GIMSI Board: Ammirati if Badami A Brignole M (responsabile progetto) Casagranda I De Seta F Furlan R Registro multicentrico prospettico costituito dai pazienti valutati dalle Sincope Unit GIMSI che utilizzano il software Syncope Web per la diagnosi e il trattamento dei pazienti con sincope Giuli S (segretaria) Santi E Ungar A

pazienti valutati dalle Sincope Unit GIMSI che utilizzano il software Syncope Web

3 Comitato Direttivo Registro GIMSI Roma, 24 febbraio 2011

4 Registro GIMSI Studi GIMSI 1. Report periodici dei dati contenuti nel database Syncope Web 2. Trial clinici prospettici basati su specifici protocolli proposti dal lboard o dalle Syncope Unit GIMSI 3. Ogni studio ha un PI che propone lo studio al board, nomina i membri dello SC, conduce lo studio e scrive il lavoro finale

Trial clinici prospettici basati su specifici protocolli proposti dal lboard o

5 Registro GIMSI Publication Policy 1. Definite dallo Steering Committee di ciascun studio 2. In ogni studio, dovrà essere riportato per esteso il Comitato Direttivo del registro GIMSI (GIMSI Registry Board) La filosofia del Registro GIMSI è di dare visibilità a chi g contribuisce in modo attivo alla produzione e all attuazione di programmi scientifici

In ogni studio, dovrà essere riportato per esteso il Comitato Direttivo del registro

7 The GIMSI registry Syncope Unit Project 2 (SUP 2) SUP 2 trial Guideline based pacing therapy for Reflex Syncope Principal Investigator: M. Brignole

8 Syncope Unit Project 2 (SUP 2) Study hypothesis DDD pacemaker therapy with rate hysteresis features is effective in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence or the total syncope burden The GIMSI registry

syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable loop recorder (ILR).

9 Syncope Unit Project 2 (SUP2) Pacing therapy for reflex syncope Study flow in brief Severe recurrent syncopes at initial evaluation Exclude cardiac syncope CI carotid sinus syndrome Asystolic (Vasis 2B) tilt test Asystolic syncope at ILR If excluded, perform CSM If yes, PM (RDR) If yes, PM (RDR) If yes, PM (RDR) If not, cardiac evaluation If not, perform Tilt Test If not, implant ILR If not, other ILRguided Rx The GIMSI registry

test Asystolic syncope at ILR If excluded, perform CSM If yes, PM (RDR) If yes, PM (RDR) If yes, PM (RDR)

10 The GIMSI registry REMOTUS trial REMOTUS trial Remote Monitoring of patients evaluated and Treated by Syncope Units of general hospitals Principal Investigator: F. Ammirati

11 REMOTUS trial Study design Aim of the REMOTUS study is to evaluate, with a prospective randomized design, the diagnostic yield of ILR and the diagnosis anticipation and consequent related therapy in patients followed by remote monitoring instead ofambulatory follow ups. Inclusion criteria Patients affected by transient loss of consciousness which is attributed to a syncopal condition, who are referred to the Syncope Unit and after evaluation are implanted with the ILR to obtain the diagnosis. The GIMSI registry

12 REMOTUS trial Study flow chart Syncope of unknown origin after evaluation ILR implant, if R wave amplitude 0,5 mv then randomization 11C 1:1 CareLink vs ambulatory FU 7 14 days after ILR implant ambulatory FU 7 14 days after ILR implant ambulatory FU ILR programming settings optimization i i if needed d CareLink kdli delivery to patient ILR programming settings optimization if needed ambulatory FU every 3 months or on patient symptoms till 1 year FU ILR programming settings optimization if needed 7days after CareLink delivery perform first transmission no or few artifacts detected CareLink transmission every 15 days or on patient symptoms till 6 month FU many artifacts detected Ambulatory FU ILR programming settings optimization CareLink transmission every month or on patient symptoms till 12 month FU The GIMSI registry

ambulatory FU every 3 months or on patient symptoms till 1 year FU ILR programming settings optimization if needed 7days after CareLink delivery perform first transmission no or few artifacts

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Studio SUP 2 Guideline based pacing therapy for Reflex Syncope

Syncope Unit Project 2 Studio SUP 2 Guideline based pacing therapy for Reflex Syncope Investigatore Principale: M. Brignole Syncope Unit Project 2 Board: Ammirati F Badami A Brignole M (responsabile progetto)