EUCTR2009-014272-21-NL进行中（未招募）不适用
Effect of additional treatment with exenatide in patients with an acute myocardial infarction: the EXAMI trial)
VU University Medical Center0 个研究点目标入组 40 人开始时间: 2009年7月20日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- >18 and < 80 years of age
- •- First myocardial infarction
- •- ST elevation of more than one mm in at least 2 separate leads on the electrocardiogram (ECG)
- •- Time from onset of complaints at least 2 hours at presentation.
- •- Delay between onset of sustained chestpain and PCI < 6 hours.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Cardiac rhythm is other than normal sinus rhythm.
- •- Patient in Killip class 3 or 4 of heart failure
- •- Cardiogenic shock defined as sustained systolic blood pressure = 80mmHg despite fluid hydration.
- •- Post cardiac resuscitation
- •- Need for intra aortic balloon counterpulsation therapy
- •- The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness
- •- No former PCI performed
- •- No recanalisation achieved of the occluded coronary artery
- •- Culprit not in segment 1,2,3,6,7,11,12,13 of the coronary artery
- •- No definite culprit
- •- More than one occluded vessel, or a more than 70% stenosis by visual assessment in a non-culprit vessel.
- •- TIMI 3 flow in culprit lesion at presentation
- •- Decreased renal function eGFR < 50ml/min
- •- Any contraindication for MRI ie: implanted electronic devices such as pacemakers, internal defibrillators, neurostimulators, implanted drug infusion devices, cochlear implants, cerebrovascular clips, claustrophobia. previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, venous umbrella spinal/intra-ventricular shunts
- •- Metal fragments in eye, head, ear, skin or shoulder.
- •- Swann-Ganz catheter.
- •- Known pre-existing left ventricular dysfunction measured by any technique (ejection fraction < 45% prior to current admission for myocardial infarction)
- •- Prior myocardial infarction
- •- Prior coronary artery bypass grafting
- •- Moderate to severe cardiac valve disease
- •- Stroke or transient ischemic attack within the previous 24 hours
- •- Serious known concomitant disease with a life expectancy of less than one year
- •- Follow up impossible
- •- Previous participation in a trial within the previous 30 days
- •- Known type I Diabetes Mellitus
- •- Known type II Diabetes Mellitus
- •- Pregnancy and/or lactation
研究者
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