NL-OMON36077已完成2 期
A pivotal trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction â¤* The ADVANCE Trial - Advance
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Acute Myocardial Infarction with culprit vessel successfully opened and stented.
- •* Myocardial Infarction Criteria:
- •* Ischemic symptoms AND
- •* Development of pathologic Q waves on the ECG; or
- •* ECG changes indicative of ischemia (ST segment elevation or depression); or
- •* New left bundle branch block: AND
- •* Creatine phosphokinase Isoenzyme (MB Form) > 100 IU/L between admission
- •and randomization
- •* Successful revascularization of the culprit lesion in a major epicardial vessel
- •(defined as the first sustained restoration of TIMI 3 flow) within 150 minutes to
- •12 hours defined as:
- •* TIMI 3 flow
- •* No more than 10% residual stenosis, by on-line QCA or visual assessment
- •* No dissection/haziness by completion of procedure
- •* No residual clot
- •* No MACCE during this hospitalization other than the MI for which the patient
- •was admitted
- •* No more than one intracoronary stent placed to treat the non bifurcating target lesion
- •during the primary PCI, with one additional stent allowed to treat coronary
- •* Multi-vessel disease: patients with maximum of one additional, non-target lesion
- •that must be in an epicardial vessel different from the target vessel can be included
- •in the study. If the non-target lesion is treated during the PCI for AMI, then both
- •lesions must meet criteria for successful revascularization in order for the patient to
- •be eligible. If the non-target lesion is not treated during this procedure, the patient
- •will be scheduled for treatment of non-target lesion no earlier than 7 months after
- •the index procedure. Should non-target lesion require ischemia-driven
- •revascularization, such procedure can be performed as needed, and the
- •revascularisation will not constitute a MACE or TVF event.
- •* Area of hypokinesia or akinesia corresponding to the territory of culprit lesion, as
- •determined by left ventriculogram at the time of primary PCI
- •* Left ventricular ejection fraction (LVEF) -30% and -45% by 2D TTE
- •* HgB and serum creatinine WNL between PCI and Liposuction
- •* Ability to undergo liposuction to obtain a minimum of 220 ml adipose tissue
排除标准
- •More than 24 hours between PCI and start of cell infusion
- •* More than twelve hours or less than 150 minutes between the onset of first
- •symptoms of AMI and revascularization defined as restoration of at least TIMI 3
- •* LVEF <30% or >45% by 2D TTE
- •* Vascular access site hematoma after PCI and before start of liposuction
- •* Staged treatment of coronary artery disease beyond 1 single non-target lesion (as
- •described above)
- •* Malignant tumor
- •* Acute or chronic bacterial or viral infectious disease
- •* Pacemaker, ICD or any other contra-indication for MRI
- •Moderate or severe COPD
- •* Current need for mechanical ventilation at the time of planned liposuction
- •* Cardiogenic shock present post PCI
- •* Prior MI, cardiomyopathy, or prior hospital admission for congestive heart failure
- •* Prior ventricular fibrillation, or sustained ventricular tachycardia between hospital
- •admission and randomization
- •* Patients with increased bleeding risk including but not limited to:
- •a. Those who have received any Glycoprotein Inhibitor within seven days
- •preceding the liposuction
- •b. Those who have received any anticoagulant within 1 hour prior to liposuction, or
- •c. Those who have an aPTT result of - 1.8 times the control value prior to
- •liposuction * Once aPTT returned to documented values below 1.8 UNL, the
- •investigator can proceed with liposuction
- •d. Administration of a thrombolytic agent within the previous 24 hours
- •* Hemodynamic instability within 8 hours prior to randomization, defined as the
- •presence of any of the following:
- •* Need for therapeutic doses of inotropic agent greater than 1 hour to maintain
- •blood pressure above 90 mm Hg before or after PCI
- •* Systolic blood pressure <90 mmHg for more than 1 hour
- •* Heart rate >110 bpm for more than 1 hour
- •* Persistent atrial fibrillation (for MRI quality)
研究者
相似试验
进行中（未招募）
不适用
A randomized clinical study of stem cells taken from fat tissue in the experimental treatment of patients with myocardial infarction (heart attack)patients with ST-elevation myocardial infarction after PCI with stentMedDRA version: 14.1Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 10007541 - Cardiac disordersEUCTR2010-022153-42-DECytori Therapeutics, Inc216
进行中（未招募）
不适用
A randomized clinical study of stem cells taken from fat tissue in the experimental treatment of patients with myocardial infarction (heart attack)patients with ST-elevation myocardial infarction after PCI with stentMedDRA version: 14.1Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 10007541 - Cardiac disordersEUCTR2010-022153-42-NLCytori Therapeutics, Inc216
进行中（未招募）
1 期
Clinical Trial for Efficacy and Safety of ARtificial Protein (Silk-elastin, P47K-WAS-MR) in Patients with Meniscus Repairmeniscus tearJPRN-jRCT2062220056Adachi Nobuo8
已完成
2 期
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)Acute Myocardial InfarctionNCT01216995Cytori Therapeutics23
尚未招募
不适用
ADD ON EFFECT OF BHUDHATRAYADIYOG WITH ORAL DIABETIC DRUGS IN MANAGEMENT OF PRAMEHACTRI/2022/01/039500Yashwant ayurvedic collage