ACTRN12613000242729尚未招募未知
The effect of intracoronary hypothermia compared to normal standard of care on infarct size and muscle damage in patients who are having a STEMI caused by thrombus
Prospex Medical III Inc0 个研究点目标入组 27 人开始时间: 2013年2月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •Patients who meet the following criteria may be included:
- •1.Age > then or = to 18 years
- •2.The patient (or next-of-kin or legal representative) provided written informed consent.
- •3.Clinical symptoms of ongoing ischemic chest pain and 12-lead ECG confirmation of acute STEMI, as defined by the following ECG criteria present upon arrival to the PCI lab:
- •a. Anterior infarct: ST-segment elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous precordial leads, V1 - V6; and/or >0.1mV in leads I, AVL.
- •b. Higher-risk inferior infarct: ST elevation >0.2mV measured 0.08 sec after the J point in 2 or more anatomically contiguous inferior leads II, III, AVF, and ST depression>0.1mV in 2 or more contiguous anterior leads,
- •4.Present to the study PCI lab within eight (8) hours of the onset of acute cardiac ischemic symptoms (such as chest pain or pressure, arm or jaw pain, dyspnea).
- •5.Be a candidate for primary PCI and have PCI planned as the immediate intervention.
- •6.Be willing and able to comply with study procedures, including returning for the cardiac MRI scan at 3+/-1 days post-procedure and be available for additional follow up.
- •7.Target coronary artery is completely or nearly completed occluded at angiography prior to PCI (TIMI 0 or 1 flow).
排除标准
- •Exclusion Criteria
- •Patients who meet any one of these criteria will be excluded from the investigation:
- •1.Is or may be pregnant.
- •2.Prior myocardial infarct in the same coronary distribution
- •3.Known pre-existing LV dysfunction (LVEF< 40%)
- •4.Administration of a thrombolytic agent for the qualifying MI
- •5.History of mental illness
- •6.Clinical suspicion of a non-thrombotic cause for ST-segment elevation (e.g., pericarditis, vasospasm, takotsubo cardiomyopathy, illicit drug use)
- •7.Allergy or contraindication to heparin, aspirin or thienopyridines
- •8.Requires an immediate surgical or procedural intervention other than PCI (e.g. CABG)
- •9.Presents in cardiogenic shock
- •10.Has undergone at least 10 minutes of cardiopulmonary resuscitation (CPR) prior to presentation to the PCI facility, or have ongoing ventricular arrhythmias
- •11.History of surgical coronary artery revascularization (e.g. CABG)
- •12.Active bleeding, coagulopathy within previous 3 months
- •13.Known significant renal disease (on dialysis, post renal transplant or eGFR<30), known severe hepatic failure (e.g., cirrhosis, or acute hepatitis)
- •14.Serious concurrent medical condition likely to result in death during the next 12 months.
- •15.Contraindication to MRI (e.g., cardiac pacemaker, ICD, nerve stimulator, brain aneurysm clips, cochlear implants, claustrophobia)
- •16.Participation in another investigational clinical research study that has not reached its primary endpoint
- •17.The investigator determines that a patient is not a good candidate for the study despite having met all the eligibility criteria.
- •18.TIMI 2 or 3 flow in the target coronary artery
研究者
相似试验
招募中
不适用
effect of eptifibatide and reteplase on primary angioplasty outcomesAcute Myocardial Infarction.Acute myocardial infarctionIRCT20170925036401N2Deputy of Research of Guilan University of Medical Sciences160
招募中
不适用
effect of eptifibatide and reteplase on primary angioplasty outcomesAcute myocardial infarctionAcute Myocardial Infarction.IRCT20170925036401N1Rasht University of Medical Sciences160
进行中（未招募）
1 期
Effects on intravascular attenuation of coronary arteries using low iodine concentrated contrast media while maintaining identical amount of iodine administered to patient per secondatypical or typical complaints of angina pectoris with no previous cardiovascular medical historylow to intermediate risk for atherosclerosis referred for coronary CTA to rule out CADEUCTR2013-002437-37-NLMaastricht University Medical Centre390
招募中
不适用
Effect of normal saline intra-coronary injection versus no injection on the complications of re-perfusion during primary angioplasty in patients with acute myocardial infarctioMyocardial infarction.Subsequent ST elevation (STEMI) myocardial infarction of unspecified siteI22.9IRCT20120215009014N316Hamedan University of Medical Sciences30
进行中（未招募）
1 期
A randomised trial to see if injecting patients' own bone marrow derived stem cells through their coronary artery changes mortality rate in patients after suffering from a heart attackMyocardial Infarction with reduced Left Ventricular ejection fractionMedDRA version: 18.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disordersEUCTR2012-001495-11-FIQueen Mary University London3,000