Altshock-2 REGISTRY

Официальное название

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

Обзор

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

Подробное описание

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.

Первичные конечные точки

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

Вторичные конечные точки (1)

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

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• ASST GOM Niguarda — Milan

Публикации

• 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

Идентификаторы

NCT: NCT04295252 · 45-12022020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗