Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement
Recruitment status was Recruiting
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Purpose
One emerging concept is that some form of injury or inflammation is a prerequisite for the success of circulating-cell participation in differentiated tissue structure and function. Once reperfusion is achieved in acute myocardial infarction, an intense inflammatory cascade is unleashed.
The architecture of the left ventricle rearranges, leading to ventricular remodeling. The “homing process”involves stem cell migration to the sites of injury or ischemia, which provides an environment that is favorable to growth and function. This microenvironment is a stimulus for homing and differentiation of stem cells of the appropriate lineage. It increases vascular permeability and expression of adhesion proteins like integrin, along with homing receptors that facilitate the attachment, which is mediated by cell-to-cell contact and chemoattractant release from local tissue injury.The migratory capacity of stem cells might be dependent on natural growth factors such as vascular endothelial growth factor (VEGF) , stromal cell–derived factor-1 (SDF-1)and stem cell factor (SCF).The expression of VEGF ,SDF-1 and SCF is highly up-regulated in hypoxic tissue, supporting the hypothesis that these factors may represent homing signals crucial to the recruitment of circulating progenitor cells to assist the endogenous repair mechanisms in the infarcted tissue. This study will examine whether cardiac rehabilitation increases the concentration of stem cell factors released into the bloodstream and if these factors are correlated with the improvement of heart function.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction |
Behavioral: cardiac rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Association Study Between Cardiac Rehabilitation and Stem Cell Mobilization in Patients With Myocardial Infarction |
- Decreased maximal oxygen consumption is noted in the patients after myocardial infarction, while rehabilitatiation improved it.
- The improvement of maximal oxygen consumption after rehabilitation is associated with improvement of perfusion status in cardiac MRI and an increased serum level of stem cell factors.
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2004 |
Exercise training has beneficial hemodynamic effects in patients with congestive heart failure.A similar benefit may be seen after MI, with an improvement in functional capacity averaging 20 percent. More important, however, is the possible effect on survival. In a meta-analysis of 24 trials examining the effect of cardiac rehabilitation after MI, there was a significant reduction in mortality with rehabilitation (odds ratio 0.81).
Previous studies focused on the effect of rehabilitation comes from the improvement of oxygen utilization in skeletal muscle. The effects on cardiac morphology and perfusion status were rather little to be addressed.
In this study, we will collect the questionaires, blood sampling for assay of stem cell factors, maximal O2 consumption, and cardiac MRI before and after cardiac rehabilitation.SDF-1 (stromal cell derived factor-1), SCF(stem cell factor), and VEGF (vasculoendothelial growth factor) will be measured by ELISA. Cardiac MRI will provide the information about (1) LV function, (2) scar size, and (3) perfusion status (dipyridamole stress MRI).
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: myocardial infarction with CK more than 3000, status post revascularization therapy, clinical stable with regular follow-up at OPD, NYHA II-III -
Exclusion Criteria:sustained ventricular arrhythmia, hypertrophy cardiomyopathy, intolerance to exercise program
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Contacts and Locations| Contact: Bai-Chin Lee, MD | 886-2-23123456 ext 3352 | lebai@ha.mc.ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Bai-Chin Lee, MD 886-2-23123456 ext 3352 lebai@ha.mc.ntu.edu.tw | |
| Contact: Ming-Fong Chen, PhD 886-2-23123456 ext 5059 mfchen@ha.mc.ntu.edu.tw | |
| Principal Investigator: Bai-Chin Lee, MD | |
| Principal Investigator: Ssu-Yuan Chen, MD | |
| Principal Investigator: Wen-Yih Tseng, MD, PhD | |
| Principal Investigator: Ming-Fong Chen, MD, PhD | |
| Principal Investigator: | Bai-Chin Lee, MD | National Taiwan University Hospital |
| Principal Investigator: | Ssu-Yuan Chen, MD | National Taiwan University Hospital |
| Principal Investigator: | Wen-Yih Tseng, MD, PhD | National Taiwan University Hospital |
| Study Director: | Ming-Fong Chen, MD, PhD | National Taiwan University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00154466 History of Changes |
| Other Study ID Numbers: | 9261701248 |
| Study First Received: | September 9, 2005 |
| Last Updated: | November 21, 2005 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Myocardial infarction, stem cell, cardiac rehabilitation |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013