NCT06475456 Pilot Italian Cardiogenic Shock Initiative

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 786 participants in total. It began in 2024-12-01 with a primary completion date of 2026-11-03.

Brief 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 Criteria

Inclusion Criteria: 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: 1. 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; 2. 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. 3. CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS) Exclusion Criteria: Patients will be excluded if any of the following conditions apply: 1. Cardiac arrest with no quantifiable or longer than 10 minutes "no-flow" time or with refractory cardiac arrest (as defined by CPR prolonging for more than 20') 2. Absolute contraindication to 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 greater than 75-year-old 5. Life expectancy \&lt; 1 year due to other reason than cardiogenic shock.

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