Registry for patients with cardiogenic shock

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

This study is collecting information on patients with cardiogenic shock in the hospital to better understand their causes and outcomes, so we can improve their care in the future.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Niguarda Hospital (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT04295252 on ClinicalTrials.gov

What this trial studies

The Altshock-2 registry aims to collect and analyze data on patients experiencing cardiogenic shock admitted to Intensive Coronary Care Units. This observational study will focus on understanding the diverse causes, clinical presentations, and outcomes of these patients, particularly as recent evidence suggests that many cases are not related to acute myocardial infarction. By documenting various factors such as aetiology, treatment approaches, and the use of mechanical support devices, the registry seeks to improve clinical phenotyping and inform future care strategies. The study will enroll all consecutive cardiogenic shock patients hospitalized from January 2020 to December 2030.

Who should consider this trial

Good fit: Ideal candidates for this study are all patients diagnosed with cardiogenic shock who are hospitalized in the participating centers.

Not a fit: Patients who do not meet the criteria for cardiogenic shock or are not hospitalized in the participating centers may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could lead to improved management strategies and outcomes for patients with cardiogenic shock.

How similar studies have performed: Previous registries focusing on acute coronary syndrome have provided valuable insights, but this study aims to explore a broader range of causes for cardiogenic shock, making it a novel approach.

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.

Where this trial is running

Milan

• ASST GOM Niguarda — Milan, Italy (Recruiting)

Study contacts

• Study coordinator: nuccia Morici, MD

Conditions Cardiogenic Shock; cardiogenic shock