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RecruitingNCT04295252Updated May 14, 2026

Altshock-2 REGISTRY

An observational study in Cardiogenic Shock, sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Niguarda Hospital · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cardiogenic Shock

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Keywords

  • cardiogenic shock
03

In context

Shock, Cardiogenic

296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 200 across 155 observational studies indexed under Shock, Cardiogenic.

Browse Shock, Cardiogenic studies →

Lead sponsor

Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All-comers cardiogenic shock patients admitted to the Intensive Coronary Care Units

Eligibility 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • cardiogenic shock patients

    All-comers cardiogenic shock patients Admitted to the Intensive Coronary Care Units

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 years

  2. Re-hospitalization

    Number of patients

    Time frame: 10 years

Secondary outcomes

  1. 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

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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-e1629. doi: 10.1097/CCM.0000000000006738. Epub 2025 Jun 12. PubMed 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. PubMed 36378673 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04295252
Lead sponsor
Niguarda Hospital
Responsible party
Sponsor
First posted
Mar 4, 2020
Start date
Jul 1, 2020
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
May 14, 2026

Study contacts

Alice Sacco, MD
Contact
alice.saccoi@ospedaleniguarda.it
+39026444 ext. 2643

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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