Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cardiogenic Shock. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Польша
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- all-cause mortality [Срок оценки: From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months]
Вторичные конечные точки (4)
- myocardial infarction [Срок оценки: From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months]
- stroke [Срок оценки: From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months]
- heart transplantation [Срок оценки: From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months]
- long-term LVAD implantation [Срок оценки: From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Польша · 2 центра
- Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland — Wroclaw
- Wroclaw Medical University — Wroclaw
Идентификаторы
NCT: NCT06697093 · KB/16/2023/N