Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- all-cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
all-cause mortality
时间窗: From the date of cardiogenic shock diagnosis recognition until the date of death from any cause assessed up to 6 months
all-cause mortality
次要结局
- myocardial infarction(From the date of cardiogenic shock diagnosis recognition until the date of first documented myocardial infarction assessed up to 6 months)
- stroke(From the date of cardiogenic shock diagnosis recognition until the date of first documented stroke assessed up to 6 months)
- heart transplantation(From the date of cardiogenic shock diagnosis recognition until the date of heart transplantation assessed up to 6 months)
- long-term LVAD implantation(From the date of cardiogenic shock diagnosis recognition until the date of long-term LVAD assessed up to 6 months)
研究者
Wiktor Kuliczkowski
MD, PhD, Associate Professor, Head of the Catheterization Laboratory at Wroclaw University Hospital
Wroclaw Medical University