Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiogenic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 2 centers
- Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland — Wroclaw
- Wroclaw Medical University — Wroclaw
Identifiers
NCT: NCT06697093 · KB/16/2023/N