Altshock-2 REGISTRY

NCT04295252 | Recruiting

• 1 other identifier: 45-12022020
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiogenic Shock

Keywords

cardiogenic shock

Outcome Measures

Primary Outcomes (2)

• 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

  10 years

• Re-hospitalization

  Number of patients

  10 years

Secondary Outcomes (1)

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

  10 years

Study Arms (1)

cardiogenic shock patients

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, 20125, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 40504883 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Alice Sacco, MD

CONTACT

+39026444; alice.saccoi@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: July 1, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

IT (1)