EUCTR2007-000339-24-NL进行中（未招募）不适用
A randomized clinical trial of AdiPOse-derived stem ceLLs in the treatment of patients with ST elevation myOcardial infarction – The APOLLO Trial - Apollo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- •1.Able to provide informed consent
- •2.Males or females 20 to 85 years of age, inclusive
- •3·Clinical symptoms consistent with AMI (pain, etc.) for a minimum of 2 and a maximum of 12 hours from onset of symptoms to PCI, and unresponsive to nitroglycerin
- •5·Anterior AMI: ·= 0.2 mV ST elevation in 2 or more V1 – V6 leads AND interval complaints and first contact < 12 hours or
- •6·Inferior AMI:= 0.1 mV ST elevation in 2 or more leads II, III, aVF AND interval complaints and first contact < 12 hours or
- •7·New left bundle branch block:
- •with interval symptoms and first contact < 12 hours or
- •8·Cardiac enzymes:
- •Two times the upper limit of normal of creatine kinase with an abnormal level of creatine kinase MB fraction
- •9·Successful revascularization of the culprit lesion in the major epicardial vessel within 12 hours of the onset of AMI symptoms (defined as (1) primary or facilitated PCI with stent implantation, resulting in TIMI 3 flow AND (2) residual stenosis no more than 10% by visual assessment or no more than 20% by on-line QCA)
- •10·Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
- •11·Left ventricular ejection fraction (LVEF) ³30% and £50%; as determined by left ventricular angiography after PCI. LVEF may be assessed by echocardiography if the left ventricular angiogram is not analyzable or available.
- •12·Ability to undergo liposuction
- •13·Negative urine pregnancy test (females only).
- •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
- •1·Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
- •2·More than 24 hours after acute PCI
- •3·Significant valvular disease
- •4·More than 12 or less than 2 hours between the onset of first symptoms of AMI and revascularization, defined as restoration of at least TIMI 3 flow
- •5·Inability to complete ADRC infusion within 24 hours of PCI
- •6·Staged treatment of coronary artery disease, or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI or CABG) planned or scheduled within 6 months after the study procedure
- •7·Need for mechanical ventilation
- •8·Cardiogenic shock
- •9·Hemodynamic instability within 24 hours prior to randomization, defined as the presence of any of the following:
- •10·Need for inotropic support
- •11·Systolic blood pressure <90 mmHg
- •12·Heart rate >100 bpm for more than 1 hour
- •13·Prior ventricular fibrillation or sustained ventricular tachycardia
- •14·Persistent atrial fibrillation
- •15·Neoplasia
- •16·Acute or chronic bacterial or viral infectious disease
- •17·Pacemaker, ICD or any other contra-indication for MRI
- •18·LVEF <30% or >50% as determined by left ventriculogram at the time of primary PCI
- •19·Moderate or severe COPD (refer to Appendix 16 for classification codes)
- •20·Pregnant and/or nursing females
- •21.Known relevant allergies or sensitivities
- •22·Serum creatinine >2.0 mg/dL
- •23·Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this study
- •24·Life expectancy <1 year
- •25·Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
研究者
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