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NCT Number: NCT04295252

Altshock-2 REGISTRY

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST GOM Niguarda

Milan, 20125, Italy

Location status: Recruiting

Location contact

Alice Sacco, MD

CONTACT

[email protected]

+026444 ext. 2308

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To provide data on profile, management, outcome, and evolution over time of CS patients admitted to ICCU

    Time frame: 10 years

    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

  2. Re-hospitalization

    Time frame: 10 years

    Number of patients

Secondary outcomes

  1. To collect data on clinical characteristics and management of cardiogenic shock patients

    Time frame: 10 years

    Accordingly to the descriptive nature of the analyses, measures of secondary outcome will not be provided

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Sacco, MD

CONTACT

[email protected]

+39026444 ext. 2643

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Mar 4, 2020
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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