NCT04321148招募中不适用
Prospective Randomized Study Comparing Impella Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients at High Risk for Contrast-induced Nephropathy Undergoing Elective Percutaneous Revascularization
Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2020年1月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Incidence rate of Contrast-induced acute kidney injury (CI-AKI)
研究概览
简要总结
This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either in combination with or without use of an Impella device during PCI. Renal function will be assessed over 6 months, potential complications (in particular bleeding and access site complications) over one month. Effects of device-assisted PCI on pathways for salt and water handling, as well as on kidney oxygenation will be detected by sequential sampling of blood and urine as well as detection of magnetic resonance imaging indicative of blood kidney oxygenation (BOLD MRI).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent obtained before any trial-related activities.
- •Patients aged 18-85 years (both inclusive) with clinical indication for coronary angiogram with potential high-risk PCI
- •Patients at high risk for contrast induced acute kidney injury as indicated by a preliminary Mehran Score ≥ 10 (contrast media volume is assumed to be < 100 ml)
排除标准
- •Previous participation in this trial. Participation is defined as randomized.
- •Patients with contraindications to use of an Impella heart pump (mural thrombus in the left ventricle; presence of a mechanical aortic valve or aortic valve stenosis (equivalent orifice area of 1.5 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); in whom severe peripheral arterial disease precluding placement of an Impella system)
- •Patients where hemodynamic support is deemed potentially required for PCI as assessed by at least one physician
- •Patients needing emergency percutaneous coronary intervention (e.g. STEMI patients)
- •Patients with acute cardiogenic shock indicated by one of the following:
- •Systolic blood pressure < 90mmHg over 30 minutes or inotropic support needed to maintain blood pressure targets.
- •Killip class III & IV
- •MCS already in place to maintain blood pressure and organ perfusion
- •Patients with on-going resuscitation
- •Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to screening OR any impairment in mental status, cognition, or any global or focal neurological deficit
- •Patients on mechanical ventilation.
- •Patients diagnosed with AKI within the last seven days prior to screening or incipient AKI. (In cases, where AKI cannot be ruled out as a cause for elevated serum creatine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is indicative of AKI)
- •Patients with an eGFR < 20 ml/min/1.73 m²
- •Suspected or known pregnancy
- •Patients with comorbidity that in the Investigator's opinion would limit life expectancy to less than 6 months
- •Patients with other medical, social, or psychological problems that, in the opinion of the Investigator, preclude them from undergoing Impella-protected PCI or the study-related procedures, evaluations, and follow-up.
- •Patients with severe anemia as indicated by hemoglobin concentrations < 8.5 g/dl at the time of screening.
- •Patients who were exposed to contrast media in the last seven days prior to the time of screening
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
- •Patients with contraindications against MRI-procedures (e.g. patients with pacemakers) are eligible for the study but will not participate in the BOLD-MRI assessment.
结局指标
主要结局
Incidence rate of Contrast-induced acute kidney injury (CI-AKI)
时间窗: 2 days after PCI
Incidence rate of AKI (Acute Kidney Injury Criteria 1-3) over 2 days after PCI
次要结局
- Mortality(up to 6 months after PCI)
- Incidence of acute kidney injury (AKIN Criteria 1-3)(over 3 days after PCI)
- Change in eGFR(at day 1 and day 3 from baseline (pre-PCI))
- Incidence of re-hospitalization for renal dysfunction(30 days and up to 6 months after PCI)
- Length of hospital stay(up to 3 days after PCI)
- Incidence of dialysis(up to 6 months after PCI)
研究者
研究点 (2)
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