Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock

Recruiting

• Conditions: Cardiogenic Shock

• Registration Number: NCT06697093
• Lead Sponsor: Wroclaw Medical University

Brief Summary

The registry objective is to get information on current epidemiology, diagnostics, treatment and outcome in patients with cardiogenic shock in Poland. Obtained information will help to plan the nationwide initiative for modern cardiogenic shock treatment with established place for mechanical circulatory support.

It is hypothesized that the treatment and outcome of cardiogenic shock, including mechanical circulatory support, are currently poor in Poland and should be improved. Unfortunately, without status quo data, efficient planning for its improvement cannot be conducted, hence the CaS-POL registry initiative.

Detailed Description

The prospective registry will be open in nature; any cardiology department in Poland with access to a 24-hour hemodynamic laboratory will be eligible to participate in the study. All participants will use an electronic CRF (Case Report Form) to anonymously collect data on the incidence, etiology, diagnosis, treatment approaches, and prognosis of patients with cardiogenic shock. Data will be collected by researchers from the medical documentation of participating centers. The data collection period will span six months, followed by a six-month prospective observation through visit in person, per telephone contact to the patient or his/her relatives or by retracting National Health Fund data in case the contact to the patient or his/her relatives is impossible.

To enable comparison with global data, collected information will include, among other aspects, the latest Society for Cardiovascular Angiography and Interventions (SCAI) classification for cardiogenic shock, the availability and application of modern short- and long-term mechanical circulatory support techniques, and the frequency of heart transplants.

Study Timeline

• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Study Start: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-04-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Cardiogenic shock patients of all etiologies in SCAI stage B, C, D, E.
• age > 18 years old
• persistent hemodynamic failure defined as systolic blood pressure of <90 mmHg for ≥ 30 minutes or the requirement for inotropic or vasopressor agents with evidence of hypoperfusion of the peripheral organs

Exclusion Criteria

• patients without return of spontaneous circulation who were considered to extracorporeal cardiopulmonary resuscitation (ECPR)
• primary septic, anaphylactic, hypovolemic shock
• post-operative cardiogenic shock
• end-stage of heart failure disqualified from mechanical circulatory support and heart transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality	From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months	all-cause mortality

Secondary Outcome Measures

Name	Time	Method
myocardial infarction	From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months	Recurrent myocardial infarction following an initial event
stroke	From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months	stroke following an initial event
heart transplantation	From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months	Heart transplantation in patients without myocardial recovery following cardiogenic shock.
long-term LVAD implantation	From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months	Long-term LVAD implantation in patients without myocardial recovery following cardiogenic shock

Trial Locations

Locations (2)

Wroclaw Medical University; 🇵🇱 Wroclaw, Poland

Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland; 🇵🇱 Wroclaw, Dolnoslaskie, Poland