SPOKE-HUB SHOCK PROTOCOL MANAGEMENT ACCORDING TO SCAI CLASS IN TURIN AND MILAN AREA

Status: Recruiting
Location: See all (16) locations...
Study Type: Observational
SUMMARY

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-support time, * Onset of symptoms to support time Inclusion criteria Prospective cohort * For conscious patients, signed and dated informed consent and consent to the processing of personal data * For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. * Aging more than 18 years * Patients admitted within 24h from the diagnosis of AMICS and SCAI SHOCK classification B to D. CS will be defined as: 1. Systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg, OR need of mechanical cardiac support (MCS); 2. At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \< 60% arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours. 3. CS SCAI B-C-D following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHFCS) Exclusion criteria 1\) Cardiac arrest with no quantifiable or longer than 10 minutes no-flow time or with refractory cardiac arrest (defined as CPR lasting more than 20') 2) Absolute contraindication to mechanical circulatory support devices 3) CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning. 4) Age less than 18 years 5) Life expectancy \< 1 year due to other reason than cardiogenic shock. Study Timetable Retrospective data collection: Jan 2016 until Dec 2019 Date of first enrolment planned: September 2024 Duration of recruitment: 24 months Follow-up period: 30 days Statistical methods A sample size of 768 patients (384 in each arm) is required to provide the study an 80% power to detect superiority in the primary endpoint with an alpha error set at 0.05 and assuming 30-day mortality estimates of 48% in the pre-protocol group and 38% in group post protocol.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

‣ All subjects participating in this clinical trial must meet the following criteria:

‣ Prospective cohort

• For conscious patients, signed and dated informed consent and consent to the processing of personal data

• For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. Aging ≥18

‣ CS will be defined as:

⁃ Systolic blood pressure (SBP) \&lt;90 mmHg or mean arterial pressure (MAP) \&lt;60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \&gt; 90 mmHg or MAP \&gt; 60 mmHg, OR need of MCS;

⁃ At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \&lt;60%; arterial lactates \&gt; 2 mmol/L; oliguria \&lt; 0.5 ml/Kg/h for at least 6 hours.

⁃ CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS)

Locations
Other Locations
Italy
Ospedale di Chivasso
RECRUITING
Chivasso
ASL TO4 Ospedale di Ciriè
RECRUITING
Cirié
Ospedale Pio XI di Desio
RECRUITING
Desio
ASL Torino 4 Ospedale di Ivrea
RECRUITING
Ivrea
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
ASST Nord Milano
RECRUITING
Milan
IRCCS San Raffaele
RECRUITING
Milan
Ospedale San Carlo Borromeo
RECRUITING
Milan
Ospedale San Paolo
RECRUITING
Milan
ASL TO5 Ospedale Santa Croce
RECRUITING
Moncalieri
Presidio Ospedaliero di Rho
RECRUITING
Rho
Ospedale Civile SS. Annunziata
RECRUITING
Savigliano
AOU Città della Salute e della Scienza
RECRUITING
Torino
Azienda Sanitaria Locale Città di Torino Ospedale Maria Vittoria
RECRUITING
Torino
San Giovanni Bosco, ASL Città di Torino
RECRUITING
Turin
Ospedale di Vimercate
RECRUITING
Vimercate
Contact Information
Primary
Alaide Chieffo, Prof
cecalaide@gmail.com
+390226437331
Backup
Mario Iannaccone, MD
mario.iannaccone@hotmail.it
+390112402851
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-12-03
Participants
Target number of participants: 786
Treatments
Pre-Protocol Cohort
Patients enrolled retrospectively between 2016 and 2019
Post-protocol Cohort
Patients enrolled prospectively between 2024 and 2026
Sponsors
Leads: Fondazione GISE Onlus
Collaborators: San Raffaele University Hospital, Italy, Mediolanum Cardio Research

This content was sourced from clinicaltrials.gov