Effect of Diagnostic Echocardiogram on Microvascular Recovery Following Acute STEMI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Myocardial salvageability index
研究概览
简要总结
The investigators propose to test the effectiveness of a technique that uses a modified commercially available ultrasound system used for cardiac imaging, and a commercially available ultrasound contrast agent (microbubbles) to break up the blood clots that cause heart attacks. The ultrasound and microbubbles will be applied as soon as possible to patients presenting to the emergency department, after an EKG confirms that a heart attack is ongoing. Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery. Following the randomized treatment, patients will be followed for the development of any complications (recurrent heart attack, heart failure, or need for defibrillator placement) as well as by echo and cardiac MRI to determine how much heart muscle was salvaged by the treatment.
详细描述
The investigators propose to test the effectiveness of a technique that uses a modified commercially available ultrasound system used for cardiac imaging, and a commercially available ultrasound contrast agent (microbubbles) to break up the blood clots that cause heart attacks. The ultrasound and microbubbles will be applied as soon as possible to patients presenting to the emergency department, after an EKG confirms that a heart attack is ongoing. Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the capillaries that are fed by this artery. Following the randomized treatment, patients will be followed for the development of any complications (recurrent heart attack, heart failure, or need for defibrillator placement) as well as by echo and cardiac MRI to determine how much heart muscle was salvaged by the treatment. A total of 250 patients will be enrolled and followed at two different sites. Randomization will be stratified at each study site. The initial site enrolling patients will be University of Sao Paulo Medical School. The other is Vrije Universiteit (VU) University Medical Center in Amsterdam.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to participating centers with chest pain and EKG evidence of an acute STEMI (two contiguous leads with >0.1 millivolt (mV) ST elevation or >0.1 ST depression in V2-V4) will be asked to participate. The inclusion criteria will be:
- •Age ≥30 years.
- •Eligible for emergent PCI/antithrombotic/antiplatelet therapy.
- •Adequate apical and/or parasternal images by echocardiography.
- •No contraindications or hypersensitivities to ultrasound contrast agents.
排除标准
- •Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- •Cardiogenic Shock
- •Life expectancy of less than two months or terminally ill.
- •Known severe cardiomyopathy.
- •Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin
- •Known large right to left intracardiac shunts.
研究组 & 干预措施
Ultrasound and microbubbles
Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery.
干预措施: percutaneous intervention (PCI) (Procedure)
Ultrasound and microbubbles
Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery.
干预措施: Microbubbles (Drug)
Ultrasound and microbubbles
Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery.
干预措施: Ultrasound (Procedure)
Standard of care
Emergent PCI/antithrombotic/antiplatelet therapy with Echocardiogram to assess Left Ventricular Ejection Fraction (LVEF) and Aspirin, Plavix, or Direct Thrombin Inhibitor.
干预措施: percutaneous intervention (PCI) (Procedure)
结局指标
主要结局
Myocardial salvageability index
时间窗: Prior to hospital discharge (48-72 hours)
The difference between extent of delayed enhancement by Gd MRI and the T2 weighted double or triple inversion spin echo assessment of risk area (defined above).
Six month event free survival (EFS)
时间窗: 6 months
The time from the start of treatment to first cardiac event or death as a first event. Cardiac events include, congestive heart failure, life threatening arrhythmias, and need for prophylactic defibrillator (primary and secondary).
Frequency of left ventricular remodeling
时间窗: 6 month follow-up
Defined as a 20% increase in end diastolic volume at the six month follow up biplane contrast enhanced echocardiogram compared to the pre-discharge contrast enhanced echocardiogram
次要结局
- Safety of contrast in this setting(at the time of procedure to 6 month follow-up)
- Frequency of > 50% ST segment resolution by EKG at six hours post PCI.(6 hours post PCI)
- Overall survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 120 months)
- Area under the Creatine Phosphokinase (CPK) versus time curve(at time of procedure)