Clinical trial NCT06697093: Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock
Official title: Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Keywords: mechanical circulatory support
myocardial infarction
Cardiogenic shock
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Polish Cardiac Society
name: Johnson & Johnson
First posted: 2024-11-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: all-cause mortality
timeFrame: From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months
Secondary outcomes:
measure: myocardial infarction
timeFrame: From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months
measure: stroke
timeFrame: From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months
measure: heart transplantation
timeFrame: From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months
measure: long-term LVAD implantation
timeFrame: From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
Study officials:
References: