Condition: Cardiogenic Shock · Sponsor: Fondazione GISE Onlus
Study Objective To evaluate the impact on 30-day mortality of the adoption of a dedicated cardiogenic shock protocol designed to improve communication and collaboration among centres to timely refer Cardiogenic Shock (CS) patients from spoke to hub centres in Turin and Milan metropolitan Area. Study Design A multicentre, observational, study, consisting of * retrospective cohort including anonymous data from electronic health records of patients admitted with acute myocardial infarction complicated by cardiogenic shock (AMICS) SCAI class B-D, from Jan 2016 until Dec 2019 * prospective cohort including all consecutive patients admitted for AMICS SCAI class B-D in the study centres Study Population and Centres 768 patients admitted in spoke hospitals for AMICS: 384 in each study cohort. Four centres - two in Milan metropolitan Area and two in Turin - will serve as hub centres, each one receiving CS patients from three referring spoke centres. In total, 16 centres will be involved in the study. Follow-up period Up to 30 days from hospital admission Primary Endpoint The primary endpoint will be the short-term mortality defined as inhospital or 30-day mortality. Secondary Endpoints * In-hospital or 30-day incidence of: 1. stroke, (fatal or non-fatal) or TIA 2. bleedings (BARC classification ≥3), 3. renal replacement therapy (CVVH / new onset of dialysis) 4. vascular complications (all complication needing intervention), 5. non-fatal myocardial infarction * Door-to-supp…
This description comes directly from the study's public registry record.
Alaide Chieffo, Prof · +390226437331 · cecalaide@gmail.com
Mario Iannaccone, MD · +390112402851 · mario.iannaccone@hotmail.it
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| Ospedale di Chivasso | Chivasso, Italy | Recruiting |
| ASL TO4 Ospedale di Ciriè | Cirié, Italy | Recruiting |
| Ospedale Pio XI di Desio | Desio, Italy | Recruiting |
| ASL Torino 4 Ospedale di Ivrea | Ivrea, Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan, Italy | Recruiting |
| ASST Nord Milano | Milan, Italy | Recruiting |
| IRCCS San Raffaele | Milan, Italy | Recruiting |
| Ospedale San Carlo Borromeo | Milan, Italy | Recruiting |
| Ospedale San Paolo | Milan, Italy | Recruiting |
| ASL TO5 Ospedale Santa Croce | Moncalieri, Italy | Recruiting |
| Presidio Ospedaliero di Rho | Rho, Italy | Recruiting |
| Ospedale Civile SS. Annunziata | Savigliano, Italy | Recruiting |
+ 4 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06475456