Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 10
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.
Objective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.
Design: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.
Innovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation
- •Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)
- •CRP elevation of ≥7 mg/l measured between 6 to 16 hours after primary PCI
- •Eligible for primary PCI
- •Age ≥18 years
- •Written informed consent
排除标准
- •Prior acute myocardial infarction, coronary artery bypass surgery or PCI.
- •Persistent hemodynamic instability (Killip class >2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.
- •The patient is febrile (temperature >38°C) or has experienced an acute infection with fever in the last 14 days.
- •CRP >15 mg/l at time of hospital admission.
- •Chronic inflammatory disease.
- •Known history of severe hepatic failure
- •Chronic kidney disease with a creatinine clearance <30ml/min./1.73m²
- •Contraindication to CMR.
- •Pre-STEMI life expectancy of <1 year
- •Participation in another interventional trial
- •Limited possibility to join the follow-up examinations (e.g. patient lives abroad)
研究组 & 干预措施
Selective CRP apheresis as an adjunct to standard of care
Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
干预措施: Selective CRP apheresis using the PentraSorb®-CRP system (Device)
Standard of care according to current guideline recommendations
结局指标
主要结局
Primary efficacy endpoint
时间窗: 5 ± 2 days post PCI
Infarct size expressed as % of left ventricular myocardial mass (LVMM) as visualized by cardiac magnetic resonance (CMR) imaging at 5 ± 2 days post PCI
次要结局
- Cardiac autonomic function: Skin sympathetic nerve activity(5 ± 2 days, 4 months, 12 months post PCI)
- Biomarker concentrations of hemodynamic stress (N-terminal pro-B-Type Natriuretic Peptide)(at baseline, 4 months, 12 months post PCI)
- Renal function (Cystatin C-based calculation of creatinine clearance)(during hospitalization for the index event)
- Cardiac autonomic function: Baroreflex sensitivity(5 ± 2 days, 4 months, 12 months post PCI)
- Safety endpoint(during hospitalization for the index event)
- All-cause mortality or hospitalization for heart failure within 12 months after randomization(within 12 months after randomization)
- Hospitalization for heart failure within 12 months after randomization(within 12 months after randomization)
- Cardiovascular mortality at 12 months(within 12 months after randomization)
- CRP concentrations(during hospitalization for the index event)
- Cardiac autonomic function: Deceleration capacity of heart rate(5 ± 2 days, 4 months, 12 months post PCI)
- CMR endpoints defined as: Left ventricular ejection fraction and microvascular obstruction and exploratory (intramyocardial hemorrhage, edema extent, myocardial salvage, native T1 mapping, strain)(at baseline, 4 months and 12 months after PCI for STEMI)
- Left ventricular thrombus formation(5 ± 2 days, 4 months, 12 months post PCI)
- Biomarker concentrations of myocardial necrosis (enzymatic infarct size; high-sensitivity troponin T)(at baseline, 4 months, 12 months post PCI)
- Cardiac autonomic function: Heart rate variability(5 ± 2 days, 4 months, 12 months post PCI)
- Renal function (eGFR)(during hospitalization for the index event)
- Cardiac autonomic function: Periodic repolarization dynamics(5 ± 2 days, 4 months, 12 months post PCI)