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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154466
First received: September 9, 2005
Last updated: May 25, 2014
Last verified: May 2014
Results First Received: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Myocardial Infarction
Intervention: Behavioral: cardiac rehabilitation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Post-infarction Training which underwent a 3-month cardiac rehabilitation program
Post-infarction Nontraining in which patients continued their usual lifestyle.
Healthy Controls For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.

Participant Flow:   Overall Study
    Post-infarction Training     Post-infarction Nontraining     Healthy Controls  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Postinfarction Training Patients 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
Postinfarction Nontraining Patients 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
Healthy 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 Total of all reporting groups

Baseline Measures
    Postinfarction Training Patients     Postinfarction Nontraining Patients     Healthy Controls     Total  
Number of Participants  
[units: participants]
  20     19     19     58  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     20     19     19     58  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 8     52  ± 9     50  ± 9     52  ± 8  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     20     19     19     58  
Region of Enrollment  
[units: participants]
       
Taiwan     20     19     19     58  



  Outcome Measures
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1.  Primary:   Myocardial Blood Flow at Baseline and 3-month Follow-up   [ Time Frame: 3 months ]

2.  Secondary:   Angiogenic Cytokines at Baseline and 3-month Follow-up   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Bai-Chin Lee
Organization: National Taiwan University Hospital
phone: 0223123456 ext 63352
e-mail: lebai@ntu.edu.tw


Publications of Results:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00154466     History of Changes
Other Study ID Numbers: 9261701248
Study First Received: September 9, 2005
Results First Received: December 6, 2012
Last Updated: May 25, 2014
Health Authority: Taiwan: Department of Health