Pilot Italian Cardiogenic Shock Initiative
NCT Number: NCT06475456
Acronym: ICSI
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cardiogenic Shock
Sponsor: Fondazione GISE Onlus
Collaborators: Mediolanum Cardio Research|San Raffaele University Hospital, Italy
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 786
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-03

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.

Primary Outcome Measures: Mortality., short-term mortality defined as inhospital or 30-day mortality., 30-days
Secondary Outcome Measures: Stroke, (fatal or non-fatal) or TIA, 30-days|Bleedings (BARC classification ≥3),, 30-days|Renal replacement therapy, CVVH / new onset of dialysis, 30-days|Vascular complications, all complication needing intervention, 30-days|Non-fatal myocardial infarction, 30-days|Door-to-support time, 30-days|Onset of symptoms to support time, 30-days