Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CLIP score
研究概览
简要总结
Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.
The CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.
The primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.
详细描述
Cardiogenic shock following acute myocardial infarction is associated with a high inflammatory response and mortality rates of approximately 40-50% despite early revascularization and intensive care treatment. Experimental and clinical evidence suggests that elevated C-reactive protein (CRP) contributes to myocardial injury, impaired tissue regeneration, and adverse outcomes.
The CRP-SHOCK trial investigates whether selective removal of circulating CRP by apheresis improves short-term risk stratification and clinical outcomes in patients with infarct-related cardiogenic shock. The intervention consists of up to three CRP apheresis sessions initiated within 5 ± 1 hours after randomization and repeated at predefined intervals using the PentraSorb®-CRP system.
The primary efficacy endpoint is the CLIP score at 66 ± 8 hours after randomization. Secondary endpoints include mortality, major adverse cardiovascular events, biomarkers of inflammation and organ function, and safety outcomes such as bleeding, stroke, and infections. The trial is conducted as a multicenter pilot study in Germany and Austria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).
- •Cardiogenic shock defined as:
- •Systolic blood pressure <90 mmHg for >30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and
- •Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output <30 mL/hour, Arterial lactate >2 mmol/L
- •C-reactive protein (CRP) level ≥7 mg/L at baseline.
- •Age ≥18 years.
- •Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.
排除标准
- •Fever (body temperature >38°C) or acute infection with fever within the last 14 days.
- •Chronic inflammatory disease.
- •Known history of severe hepatic failure.
- •Chronic kidney disease with creatinine clearance <30 mL/min/1.73 m² prior to hospital admission.
- •Life expectancy <12 months prior to cardiogenic shock.
- •Participation in another interventional clinical trial.
- •Pregnancy.
- •Resuscitation duration >30 minutes.
- •Cardiogenic shock due to causes other than acute myocardial infarction.
- •Onset of cardiogenic shock >12 hours before randomization.
- •Age >80 years.
结局指标
主要结局
CLIP score
时间窗: 66 ± 8 hours after randomization
The CLIP score (Cystatin C, Lactate, Interleukin-6 and N-terminal pro B-type natriuretic peptide \[NT-proBNP\] score) is a biomarker-based risk score for predicting 30-day mortality in cardiogenic shock complicating acute myocardial infarction. It is calculated via a logistic regression model using the four biomarkers (Cystatin C, Lactate, Interleukin-6, and NT-proBNP), yielding a probability score ranging from 0 to 1 (or 0% to 100% when multiplied by 100). Higher scores indicate a higher probability of 30-day mortality, i.e., a worse outcome.
次要结局
- Major adverse cardiovascular events (MACE)(30 days)
- All-cause mortality(30 days)
- Cardiovascular mortality(30 days)
- CLIP score over time(18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization)
- Individual components of the CLIP score(18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization)
- C-reactive protein (CRP) concentration(9 ± 1 hours, 34 ± 4 hours, 58 ± 6 hours, and 66 ± 8 hours after randomization)
- Peak NT-proBNP concentration(During index hospitalization)
- Peak serum creatinine concentration(During index hospitalization)
- Cardiac power index(18 ± 4 hours, 42 ± 6 hours, and 66 ± 8 hours after randomization)
- Time to hemodynamic stabilization(hospital discharge)
- Duration of catecholamine therapy(hospital discharge)
- Length of intensive care unit stay(hospital discharge)
- Length of hospital stay(hospital discharge)