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Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement - Article


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Cardiac Risk


Clinical Trial: Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement

This study is currently recruiting patients.
Verified by National Taiwan University Hospital November 2003

Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00154466

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
 Behavior: cardiac rehabilitation

MedlinePlus related topics:  Heart Attack

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: An Association Study Between Cardiac Rehabilitation and Stem Cell Mobilization in Patients with Myocardial Infarction

Further Study Details: 
Primary Outcomes: Decreased maximal oxygen consumption is noted in the patients after myocardial infarction, while rehabilitatiation improved it.
Secondary Outcomes: 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.
Expected Total Enrollment:  50

Study start: 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 stess MRI).

Eligibility

Ages Eligible for Study:  35 Years   -   70 Years,  Genders Eligible for Study:  Male
Criteria

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

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00154466

Bai-Chin Lee, MD      886-2-23123456  Ext. 3352    lebai@ha.mc.ntu.edu.tw

Taiwan
      National Taiwan University Hospital, Taipei,  100,  Taiwan; Recruiting
Bai-Chin Lee, MD  886-2-23123456  Ext. 3352    lebai@ha.mc.ntu.edu.tw 
Ming-Fong Chen, PhD  886-2-23123456  Ext. 5059    mfchen@ha.mc.ntu.edu.tw 
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

Study chairs or principal investigators

Bai-Chin Lee, MD,  Principal Investigator,  National Taiwan University Hospital   
Ssu-Yuan Chen, MD,  Principal Investigator,  National Taiwan University Hospital   
Wen-Yih Tseng, MD, PhD,  Principal Investigator,  National Taiwan University Hospital   
Ming-Fong Chen, MD, PhD,  Study Director,  National Taiwan University Hospital   

More Information

Study ID Numbers:  9261701248
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00154466
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13


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Page Updated: February 22, 2005
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