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

Last updated: March 26, 2025
Sponsor: Wroclaw Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Heart Failure

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT06697093
KB/16/2023/N
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofhypoperfusion of the peripheral organs

Exclusion

Exclusion Criteria:

  • patients without return of spontaneous circulation who were considered toextracorporeal cardiopulmonary resuscitation (ECPR)

  • primary septic, anaphylactic, hypovolemic shock

  • post-operative cardiogenic shock

  • end-stage of heart failure disqualified from mechanical circulatory support andheart transplantation

Study Design

Total Participants: 500
Study Start date:
April 01, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

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

    Wroclaw, Dolnoslaskie 50-556
    Poland

    Site Not Available

  • Wroclaw Medical University

    Wroclaw, 50-556
    Poland

    Active - Recruiting

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