Clinical trial NCT00154466: Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement
Official title: An Association Study Between Cardiac Rehabilitation and Stem Cell Mobilization in Patients With Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial infarction, stem cell, cardiac rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 58
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

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Primary outcomes:
measure: Myocardial Blood Flow at Baseline and 3-month Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Angiogenic Cytokines at Baseline and 3-month Follow-up
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Bai-Chin Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Ssu-Yuan Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Wen-Yih Tseng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Ming-Fong Chen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lee BC, Hsu HC, Tseng WY, Su MY, Chen SY, Wu YW, Chien KL, Chen MF. Effect of cardiac rehabilitation on angiogenic cytokines in postinfarction patients. Heart. 2009 Jun;95(12):1012-8. doi: 10.1136/hrt.2008.153510. Epub 2009 Mar 19.