ClinicalTrials.Veeva

Menu

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

National Taiwan University logo

National Taiwan University

Status

Completed

Conditions

Myocardial Infarction

Treatments

Behavioral: cardiac rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT00154466
9261701248

Details and patient eligibility

About

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.

Full 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).

Enrollment

58 patients

Sex

Male

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 3 patient groups, including a placebo group

cardiac rehabilitation
Experimental group
Description:
Those in the training group participated in a 3-month rehabilitation training program at an exercise intensity of 55% to 70% of peak oxygen uptake (VO2.
Treatment:
Behavioral: cardiac rehabilitation
postinfarction patients
No Intervention group
Description:
those in the nontraining group continued their usual lifestyle
healthy controls
Placebo Comparator group
Description:
Age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems