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

Wroclaw Medical University500 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Cardiogenic Shock

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

myocardial infarction

Recurrent myocardial infarction following an initial event

Time frame: 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

Time frame: 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.

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

Long-term LVAD implantation in patients without myocardial recovery following cardiogenic shock

Time frame: From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months