NCT02509832已完成不适用
COOL-AMI EU PILOT TRIAL: A Multicenter, Prospective, Randomized Controlled Trial To Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention in Patients With ACUTE MYOCARDIAL INFARCTION
ZOLL Circulation, Inc., USA20 个研究点 分布在 8 个国家目标入组 100 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period
研究概览
简要总结
COOL AMI EU Pilot Trial: A Multicenter, Prospective, Randomized Controlled Trial to Assess Cooling as an adjunctive Therapy to Percutaneous Intervention in Patients with Acute Myocardial Infarction.
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
详细描述
Evaluate the retention of subjects after integrating therapeutic hypothermia using the ZOLL Proteus IVTM System into existing STEMI treatment protocols for subjects who present with acute anterior myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •All Inclusion Criteria must be answered YES for subject to be eligible for trial Inclusion Criteria:
- •≥ 18 years of age.
- •symptoms consistent with AMI (chest pain, unresponsive to nitroglycerin, ≥ 30 minutes and < 6 hours.
- •Anterior MI with ST-segment elevation of 0.2 mV in two or more anterior contiguous precordial leads.
- •Eligible for PCI.
- •Opportunity for at least 10 minutes of cooling with the Proteus IVTM System prior to PCI.
- •Written, informed consent to participate in this clinical trial.
排除标准
- •All Exclusion Criteria must be answered NO for subject to be eligible for trial inclusion.
- •Previous myocardial infarction.
- •Cardiogenic shock (systolic blood pressure [SBP] <80 mmHg and non-responsive to fluids, or SBP <100 mmHg with vasopressors, or requirement for an intra-aortic balloon pump [IABP]).
- •Resuscitated cardiac arrest, atrial fibrillation, or Killip risk stratification class II through IV
- •Aortic dissection or requires an immediate surgical or procedural intervention other than PCI
- •Congestive Heart Failure (CHF), hepatic failure, end- stage kidney disease or severe renal failure (clearance < 30ml/min/1.73m2).
- •Fever (temperature > 37.5 °C) or infection with fever in the last 5 days.
- •Previous CABG.
- •Stroke within 90 days of admission.
- •Cardio-pulmonary decompensation present or imminent
- •Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis (e.g., cryoglobulinemia, sickle cell disease, serum cold agglutinins) or vasospastic disorders (such as Raynaud's or thromboangitis obliterans)
- •Hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •History of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anemia, or will refuse blood transfusions.
- •Height of <1.5 meters (4 feet 11 inches).
- •Hypersensitivity to buspirone hydrochloride or Pethidine (Meperidine) and/or treatment with a monoamine oxidase inhibitor in the past 14 days.
- •History of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the physician would be incompatible with Pethidine administration.
- •Inferior Vena Cava filter in place (IVC).
- •The patient has a pre-MI life expectancy of <1 year due to underlying medical conditions or pre-existing co-morbidities.
- •Known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions.
- •Currently enrolled in another investigational drug or device trial that has not completed the primary endpoint.
- •Apprehension or unwilling to undergo the required MRI imaging at follow-up, has a documented or suspected diagnosis of claustrophobia, or has Gadolinium allergy
- •Received thrombolytic therapy en route to the hospital
- •Clinical evidence of spontaneous reperfusion as observed symptomatically and/ or from ECG findings (partial or complete ST resolution in ECG before randomization) upon admission
- •Vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)
- •Female who is known to be pregnant.
结局指标
主要结局
Proportion of all subjects who complete the follow-up and cMR imaging requirements at 30-day follow up period
时间窗: 30 day
次要结局
- 1. Anterior Infarct Size (IS) as assessed by Cardiac Magnetic Resonance (cMR) at 4 - 6 days following the index procedure for subjects in Test and Control Arms(4 - 6 days)
研究者
研究点 (20)
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