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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
| Zunyi Medical College | OTHER |
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The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who underwent intracoronary transfer of autologous bone marrow mesenchymal stem cells.
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells, autologous bone marrow mesenchymal stem cells transplantation. Patients between 30 and 75 years of age who receive autologous bone marrow mesenchymal stem cells transplant may be eligible for this study. These patients receive autologous bone marrow mesenchymal stem cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.
Heart function tests may include the following:
Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
MRI evaluates function of the heart chambers the beating motion of the muscle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A: Atorvastatin | Placebo Comparator | Atorvastatin routine dose + placebo transplantation |
|
| Phase A: Low dose BMMSC | Experimental | Atorvastatin routine dose + low dose BMMSC Transplantation |
|
| Phase A: Middle dose BMMSC | Experimental | Atorvastatin routine dose + middle dose BMMSC Transplantation |
|
| Phase A: High dose BMMSC | Experimental | Atorvastatin routine dose + high dose BMMSC Transplantation |
|
| Phase B: Atorvastatin | Placebo Comparator | Atorvastatin routine dose + placebo transplantation |
|
| Phase B: Atorvastatin+Transplantation | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Routine dose of Atorvastatin therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in left ventricular ejection fraction from baseline to 12 months' | Changes in left ventricular ejection fraction from baseline to 12 months' by MRI | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Qian, Doctor | Contact | 861068314466 | ahqhy712@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31829095 | Derived | Xu JY, Qian HY, Huang PS, Xu J, Xiong YY, Jiang WY, Xu Y, Leng WX, Li XD, Chen GH, Tang RJ, Huang CR, Hu MJ, Jin C, Wu Y, Zhang J, Qian J, Xu B, Zhao SH, Lu MJ, Shen R, Fang W, Wu WC, Chen X, Wang Y, Li W, Lu XF, Jiang XF, Ma CC, Li JW, Geng YJ, Qiao SB, Gao RL, Yang YJ. Transplantation efficacy of autologous bone marrow mesenchymal stem cells combined with atorvastatin for acute myocardial infarction (TEAM-AMI): rationale and design of a randomized, double-blind, placebo-controlled, multi-center, Phase II TEAM-AMI trial. Regen Med. 2019 Dec;14(12):1077-1087. doi: 10.2217/rme-2019-0024. Epub 2019 Dec 12. |
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Atorvastatin routine dose+ Optimal dose BMMSC Transplantation |
|
| Phase B: Intensive Atorvastatin | Placebo Comparator | Atorvastatin Intensive dose + placebo transplantation |
|
| Phase B: Intensive Atorvastatin+Transplantation | Experimental | Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation |
|
|
| Intensive Atorvastatin | Drug | Intensive dose of Atorvastatin therapy |
|
| Low dose BMMSC | Drug | Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation |
|
| Middle dose BMMSC | Drug | Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation |
|
| High dose BMMSC | Drug | High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation |
|
| Transplantation | Drug | Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
| D013514 | Surgical Procedures, Operative |
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