Altshock-2 REGISTRY

Official title

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

Overview

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

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.

Primary outcome measures

• To provide data on profile, management, outcome, and evolution over time of CS patients admitted to ICCU [Time frame: 10 years]
• Re-hospitalization [Time frame: 10 years]

Secondary outcome measures (1)

• To collect data on clinical characteristics and management of cardiogenic shock patients [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• ASST GOM Niguarda — Milan

Publications

• Pagnesi M, Riccardi M, Sacco A, Viola G, Oliva F, Frea S, Briani M, Bertoldi LF, Bertaina M, Potena L, Valente S, Marini M, De Ferrari GM, D'Ettore N, Cardinale A, Camporotondo R, Rota M, Tavazzi G, Morici N, Pappalardo F, Metra M; Altshock-2 Investigators. Lactate Values and Mortality in Patients With Cardiogenic Shock: Insights From the Altshock-2 Registry. Crit Care Med. 2025 Aug 1;53(8):e1620- PMID 40504883
• Morici N, Frea S, Bertaina M, Sacco A, Corrada E, Dini CS, Briani M, Tedeschi M, Saia F, Colombo C, Rota M, Oliva F, Iannaccone M, De Ferrari GM, Sionis A, Kapur NK, Tavazzi G, Pappalardo F. SCAI stage reclassification at 24 h predicts outcome of cardiogenic shock: Insights from the Altshock-2 registry. Catheter Cardiovasc Interv. 2023 Jan;101(1):22-32. doi: 10.1002/ccd.30484. Epub 2022 Nov 15. PMID 36378673

Identifiers

NCT: NCT04295252 · 45-12022020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗