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NCT Number: NCT06697093

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland, Wroclaw, Lower Silesian Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. all-cause mortality

    Time frame: 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 outcomes

  1. myocardial infarction

    Time frame: 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

  2. stroke

    Time frame: 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

  3. heart transplantation

    Time frame: 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.

  4. long-term LVAD implantation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mikołaj Błaziak, MD

CONTACT

[email protected]

+48 71 736 42 51

Wiktor Kuliczkowski, MD,PhD

CONTACT

[email protected]

+48 71 736 42 51

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Collaborators

  • Johnson & Johnson
  • Polish Cardiac Society

Registry information

Official study title

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

Acronym: CaS-POL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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