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

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ClinicalTrials.gov Identifier: NCT00154466
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myocardial Infarction
Intervention Behavioral: cardiac rehabilitation
Enrollment 58
Recruitment Details This prospective randomised controlled study was approved by the ethics committee of the National Taiwan University Hospital. Between August 2004 and December 2005, 91 postinfarction patients were informed about the trial. Thirty-seven refused to participate and 15 did not meet the inclusion criteria.
Pre-assignment Details Inclusion criteria:a successful primary stenting, a clinically stable course after MI, and no ischemia on exercise testing. Exclusion criteria: effort angina, Af, sustained ventricular arrhythmia, NYHA functional class IV, exercise-limiting diseases, severe pulmonary or renal disease, an implanted pacemaker, or claustrophobia.
Arm/Group Title Post-infarction Training Post-infarction Nontraining Healthy Controls
Hide Arm/Group Description which underwent a 3-month cardiac rehabilitation program in which patients continued their usual lifestyle. For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.
Period Title: Overall Study
Started 20 19 19 [1]
Completed 20 19 19
Not Completed 0 0 0
[1]
Healthy controls underwent the test of myocardial perfusion only at baseline.
Arm/Group Title Postinfarction Training Patients Postinfarction Nontraining Patients Healthy Controls Total
Hide Arm/Group Description 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls. 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls. 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls. Total of all reporting groups
Overall Number of Baseline Participants 20 19 19 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
19
 100.0%
19
 100.0%
58
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 19 participants 58 participants
52  (8) 52  (9) 50  (9) 52  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 19 participants 58 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
19
 100.0%
19
 100.0%
58
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 20 participants 19 participants 19 participants 58 participants
20 19 19 58
1.Primary Outcome
Title Myocardial Blood Flow at Baseline and 3-month Follow-up
Hide Description First-pass, contrast-enhanced myocardial perfusion images acquired for 80 heart beats in the left ventricle. Short-axis views were obtained after intravenous administration of gadodiamide. Perfusion studies were performed at rest and during the stress induced by a 4 min infusion of dipyridamole at a concentration of 0.14 mg/kg of body weight per minute.To determine absolute MBF values at rest and stress status, we adopted a model-independent deconvolution method proposed by Jerosch-Herold et al, a method that was previously validated in experimental animal studies by comparison with blood-flow measurements with radiolabelled microspheres.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. Healthy controls underwent the test of myocardial perfusion only at baseline. The analysis was intention-to-treat.
Arm/Group Title Post-infarction Training Post-infarction Nontraining
Hide Arm/Group Description:
Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: ml/min/g
Change of stress MBF in the remote myocardium 0.62  (0.83) -0.27  (0.56)
Change of stress MBF in the infarcted myocardium 0.44  (0.71) 0  (0.46)
2.Secondary Outcome
Title Angiogenic Cytokines at Baseline and 3-month Follow-up
Hide Description Angiogenic cytokines such as vascular endothelial growth factor (VEGF), stromal-derived factor-1 (SDF-1) and stem cell factor (SCF) are known to increase the formation of new vessels at ischaemic sites and thus enhance myocardial perfusion. To rule out any effect of short-term exercise on cytokines levels, blood samples were always taken after at least 72 h of physical inactivity and overnight fasting when the subject had rested in the sitting position for at least 10 min. The plasma samples were immediately frozen and stored at −70°C. High-sensitivity ELISA (Bender MedSystems, R&D) were used to measure plasma levels of SCF, SDF-1 and VEGF according to the manufacturer’s protocols.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
We calculated that we would need 18 patients in each group to achieve a power of at least 80% to detect a 20% difference in MBF change between study groups, with a two-sided significance level of p<0.05, and a 20% increase for the stress MBF change from baseline to 3 months' follow-up. The analysis was intention-to-treat.
Arm/Group Title Post-infarction Training Post-infarction Nontraining Healthy Controls
Hide Arm/Group Description:
39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
19 age- and sex-matched healthy volunteers
Overall Number of Participants Analyzed 20 19 19
Mean (Standard Deviation)
Unit of Measure: pg/ml
Change of stromal-derived factor-1 -196  (209) -68  (175) -57  (200)
Change of vascular endothelial growth factor 0.70  (1.41) 0.95  (1.46) -1.2  (2.92)
Change of stem cell factor 20  (120) 17  (47) -18  (60)
Time Frame Mean time from the onset of MI to initial evaluation was 8.3 (3.4) months. The groups did not differ in medication taken.No patients died, were hospitalized for coronary intervention, or had worsening symptoms during the 3-month study period.
Adverse Event Reporting Description At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac MRI and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacological treatment supervised by their physicians.
 
Arm/Group Title Postinfarction Training Patients Postinfarction Nontraining Patients Healthy Controls
Hide Arm/Group Description 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls. 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls. 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
All-Cause Mortality
Postinfarction Training Patients Postinfarction Nontraining Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Postinfarction Training Patients Postinfarction Nontraining Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Postinfarction Training Patients Postinfarction Nontraining Patients Healthy Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/19 (0.00%) 
First, our trial is small size. Second, these results are applicable only for male patients less than 65 years old with ST-segment elevation MI after successful PCI. Third, the source of angiogenic cytokines cannot be elucidated.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bai-Chin Lee
Organization: National Taiwan University Hospital
Phone: 0223123456 ext 63352
EMail: lebai@ntu.edu.tw
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00154466     History of Changes
Other Study ID Numbers: 9261701248
First Submitted: September 9, 2005
First Posted: September 12, 2005
Results First Submitted: December 6, 2012
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014