Altshock-2 REGISTRY

Study Overview
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Brief Summary
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The study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the Intensive Coronary Care Units

Detailed Description
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Cardiogenic shock (CS) is the most severe form of acute heart failure. Data on epidemiology of CS have been drawn from previously published registries focussing on acute coronary syndrome (ACS) and myocardial infarction (AMI). Indeed, CS occurs in 5-7% of patients presenting with ACS and ACS has been reported as the most prevalent cause of CS, accounting for about 80% of cases. However, recent evidences in a contemporary cohort in North America have shown that more than two-thirds of all cardiogenic shock cases were related to causes other than AMI and that these patients had outcomes at least as poor as patients with AMI-CS. Given the high short-term mortality of these patients and the need for developing dedicated cardiac shock centres and systems of care to time our interventions, it is of utmost importance to achieve a better clinical phenotyping of the heterogeneous causes and presentations of CS patients and carefully perform research outcome. Accordingly, the Altshock-2 registry will represent a unique opportunity to evaluate the full spectrum of CS admitted in Intensive Coronary Care Units and to collect a selected number of variables related to aetiology, clinical presentation, ongoing pharmacological treatments, use of mechanical support devices and outcome.

Official Title
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Cardiogenic Shock: a Prospective National Registry to Get Insights in Patients' Profile, Management and Outcome

Conditions
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Cardiogenic Shock

Participation Criteria
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Eligibility Criteria
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All consecutive CS patients hospitalized in the above reported centres between January 2020 and December 2030. Cardiogenic shock is defined as: 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 MCS; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiogenic shock patients<br>All-comers cardiogenic shock patients Admitted to the Intensive Coronary Care Units | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide data on profile, management, outcome, and evolution over time of CS patients admitted to ICCU | No formal sample size calculation was used to manage enrolment in the registry since the goal is to obtain participation by all possible eligible patients. No formal pre-specified hypothesis testing is planned. All analyses will be descriptive in nature Accordingly, measures of primary outcome will not be provided | 10 years | 
| Re-hospitalization | Number of patients | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data on clinical characteristics and management of cardiogenic shock patients | Accordingly to the descriptive nature of the analyses, measures of secondary outcome will not be provided | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiogenic shock