Cardiogenic ShockCaS-POLNCT06697093
Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock
An observational study of Cardiogenic Shock, run by Wroclaw Medical University at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 500 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Apr 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Not yet recruiting
Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland
Wroclaw, Lower Silesian Voivodeship, 50-556
Wiktor Kuliczkowski, MD, PhD, +48 71 736 42 51, wiktor.kuliczkowski@umw.edu.pl
- Recruiting
Wroclaw Medical University
Wroclaw, 50-556
Maja Pekala, +48717840697, m.pekala@umw.edu.pl
About this study
Official title: Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Keywords
- mechanical circulatory support, myocardial infarction, Cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause mortality
Measured: 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
Recurrent myocardial infarction following an initial event
Measured: From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months
stroke
stroke following an initial event
Measured: From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months
heart transplantation
Heart transplantation in patients without myocardial recovery following cardiogenic shock.
Measured: From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months
long-term LVAD implantation
Long-term LVAD implantation in patients without myocardial recovery following cardiogenic shock
Measured: From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Cardiac Society, Johnson & Johnson
- Responsible party
- Principal investigator, Wiktor Kuliczkowski, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697093
- Sponsor's protocol ID
- KB/16/2023/N
- Acronym
- CaS-POL
- Status last verified
- Mar 2025
- First submitted
- 6 Nov 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL
- ClinicalTrials.gov ID
- NCT06697093
- Acronym / sponsor ID
- CaS-POL / KB/16/2023/N
- Conditions
- Cardiogenic Shock
- Keywords
- mechanical circulatory support, myocardial infarction, Cardiogenic shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Polish Cardiac Society, Johnson & Johnson
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
stroke
Time frame: From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months
heart transplantation
Time frame: From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Wroclaw Medical University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wiktor Kuliczkowski, MD,PhD (+48 71 736 42 51, wiktor.kuliczkowski@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.