Altshock-2 REGISTRY

Cardiogenic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295252
• Other study ID #: 45-12022020
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2031

Study information

• Verified date: March 2023
• Source: Niguarda Hospital
• Contact: nuccia Morici, MD
• Phone: +39026444
• Email: nuccia.morici[@]ospedaleniguarda.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Italy	ASST GOM Niguarda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Re-hospitalization	Number of patients	10 years
Secondary	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	10 years