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Altshock-2 REGISTRY

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04295252
Enrollment
3000
Registered
2020-03-04
Start date
2020-07-01
Completion date
2031-12-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

Keywords

cardiogenic shock

Brief summary

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.

Interventions

None listed

Sponsors

Niguarda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All consecutive CS patients hospitalized in the above reported centres between January 2020 and December 2030. Cardiogenic shock is 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 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.

Design outcomes

Primary

MeasureTime frameDescription
To provide data on profile, management, outcome, and evolution over time of CS patients admitted to ICCU10 yearsNo 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
Re-hospitalization10 yearsNumber of patients

Secondary

MeasureTime frameDescription
To collect data on clinical characteristics and management of cardiogenic shock patients10 yearsAccordingly to the descriptive nature of the analyses, measures of secondary outcome will not be provided

Countries

Italy

Contacts

CONTACTAlice Sacco, MD
alice.saccoi@ospedaleniguarda.it+39026444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026