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

NCT06697093 | Recruiting DMC

• 1 other identifier: KB/16/2023/N
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiogenic Shock

Keywords

mechanical circulatory support; myocardial infarction; Cardiogenic shock

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  all-cause mortality

  From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months

Secondary Outcomes (4)

• myocardial infarction

  From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months

• stroke

  From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months

• heart transplantation

  From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months

• long-term LVAD implantation

  From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months

Study Arms (1)

cardiogenic shock patients

The registry will include all patients presenting with primary cardiogenic shock. All medical interventions will be conducted based on established clinical indications.

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 patients admitted to the Intensive Care Unit (ICU) in the Cardiology, Cardiac Surgery, or to the Anesthesiology departments with a clinically evident cardiac etiology of shock.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead
• Polish Cardiac Society: collaborator
• Johnson & Johnson: collaborator

Study Sites (2)

Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

NOT YET RECRUITING

Wroclaw Medical University

Wroclaw, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wiktor Kuliczkowski, MD,PhD

CONTACT

+48 71 736 42 51; wiktor.kuliczkowski@umw.edu.pl

Mikołaj Błaziak, MD

CONTACT

+48 71 736 42 51; blaziak.mikolaj@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor, Head of the Catheterization Laboratory at Wroclaw University Hospital

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 20, 2024
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)