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

NCT ID: NCT06697093

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Cardiogenic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polish Cardiac Society

OTHER

Sponsor Role collaborator

Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wiktor Kuliczkowski

MD, PhD, Associate Professor, Head of the Catheterization Laboratory at Wroclaw University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status NOT_YET_RECRUITING

Wroclaw Medical University

Wroclaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Wiktor Kuliczkowski, MD,PhD

Role: CONTACT

+48 71 736 42 51

Mikołaj Błaziak, MD

Role: CONTACT

+48 71 736 42 51

Facility Contacts

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Wiktor Kuliczkowski, MD, PhD

Role: primary

+48 71 736 42 51

Maja Pekala

Role: primary

+48717840697

Other Identifiers

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KB/16/2023/N

Identifier Type: -

Identifier Source: org_study_id

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