EUCTR2010-022153-42-DE进行中（未招募）不适用
A phase II trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction – The ADVANCE Trial - Advance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 216
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
- •ST-segment Elevation Myocardial Infarction (STEMI)Criteria:
- •o Ischemic symptoms AND
- •-Development of pathologic Q waves on the ECG; or
- •-ECG changes indicative of severe ischemia (ST segment elevation and/or reciprocal depression); or
- •- New left bundle branch block; AND
- •- Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal 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 from the time of symptom onset defined as:
- •-TIMI 3 flow
- •-No more than 10% residual stenosis, by online 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 dissection
- •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 revascularization will not constitute a MACCE or target vessel failure (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, or left ventricular wall motion abnormalities (at least 2/18 segments) in the territory of the culprit lesion as assessed by 2D TTE
- •Hemoglobin and serum creatinine within normal limits between PCI and liposuction
- •Ability to undergo liposuction to obtain a minimum of 300 mL adipose tissue, as assessed by the physician performing the liposuction procedure
- •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
- •More than 24 hours between PCI and start of liposuction
- •Clinically significant (greater than TIMI ‘minimal’ bleeding, per Appendix 11) 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
- •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:
- •-Those who have received any glycoprotein IIb/IIIa inhibitor within seven days preceding the liposuction
- •-Those who have received any anticoagulant within 1 hour prior to liposuction, or
- •-Those who have an aPTT result of = 1.8 times the control value 1 hour prior to liposuction – once aPTT returns to a documented value below 1.8 upper limit of normal, liposuction can start
- •-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 mmHg 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)
- •Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the trial
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-NLCytori Therapeutics, Inc216
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 Trialheart attackST elevated myocardial infarction10028593NL-OMON36077Cytori Therapeutics Inc.40
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
已完成
2 期
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background MethotrexateRheumatoid ArthritisNCT02387762Acerta Pharma BV31
尚未招募
2 期
Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine TumorsNeuroendocrine TumorsNCT06764368Beijing Chest Hospital39