NCT02070913已完成不适用
A Single-Center Case Series Clinical Study to Assess the Feasibility of Integrating Therapeutic Hypothermia Using the ZOLL IVTM System as an Adjunctive Therapy to Percutaneous Coronary Intervention in Patients With AMI
ZOLL Circulation, Inc., USA23 个研究点 分布在 8 个国家目标入组 352 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 23
- 主要终点
- Time from hospital arrival to Percutaneous Coronary Intervention (PCI).
研究概览
简要总结
A single-center, prospective case series clinical study consecutively enrolling up to 10 patients with expected duration of 12 months or less. The study objectives are to evaluate retention and the feasibility of integrating therapeutic hypothermia using the ZOLL IVTM System.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •The patient is 18 years of age.
- •The patient must have symptoms consistent with AMI
- •MI with ST-segment elevation
- •The patient is eligible for PCI.
- •The expected timing of the treatment pathway for the patient will allow for at least 10 minutes of cooling with the IVTM System prior to PCI.
- •The patient or patient legal representative is willing to provide written, informed consent to participate in this clinical study.
排除标准
- •The patient has had a previous myocardial infarction
- •The patient is experiencing cardiogenic shock
- •The patient is experiencing acute pulmonary edema.
- •The patient is presenting with cardiac arrest.
- •The patient is presenting with Killip risk stratification class II through IV.
- •The patient is presenting with Atrial Fibrillation.
- •The patient has a history of a prior large myocardial infarct or an infarct in the same segment that is currently affected.
- •The patient requires an immediate surgical or procedural intervention other than PCI
- •The patient has an aortic dissection.
- •The patient has hepatic failure.
- •The patient has end stage kidney disease.
- •The patient is febrile
- •Known chronic Congestive Heart Failure (CHF).
- •Known previous CABG.
- •Known recent stroke
- •Cardio-pulmonary decompensation that has occurred en route to the hospital
- •Contraindications to hypothermia
- •The patient has a known hypersensitivity or contraindication to aspirin, heparin, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •The patient has a known history of coagulopathy
- •The patient is known to be pregnant
- •The patient has a known hypersensitivity to antishivering medications.
- •Patient has a known history of severe hepatic or renal impairment.
- •The patient has an Inferior Vena Cava filter in place (IVC).
- •The patient has a life expectancy of less than 1 year
- •The patient has a known, unresolved history of drug use
- •The patient is currently enrolled another investigational drug or device trial
结局指标
主要结局
Time from hospital arrival to Percutaneous Coronary Intervention (PCI).
时间窗: 24 hours
Time from hospital arrival to initiation of cooling.
时间窗: 24 hours
Proportion of subjects achieving target temperature.
时间窗: 24 hours
次要结局
- Proportion of those enrolled that complete the study protocol.(24 hours)
研究者
研究点 (23)
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