Trial Outcomes & Findings for Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement (NCT NCT00154466)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

3 months

Results posted on

2014-06-26

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20	19	19
Overall Study COMPLETED	20	19	19
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Postinfarction Training Patients n=20 Participants 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 n=19 Participants 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 n=19 Participants 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.	Total n=58 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 8 • n=5 Participants	52 years STANDARD_DEVIATION 9 • n=7 Participants	50 years STANDARD_DEVIATION 9 • n=5 Participants	52 years STANDARD_DEVIATION 8 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants	19 participants n=7 Participants	19 participants n=5 Participants	58 participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	58 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Post-infarction Training n=20 Participants 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.	Post-infarction Nontraining n=19 Participants 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.	Healthy Controls 19 age- and sex-matched healthy volunteers
Myocardial Blood Flow at Baseline and 3-month Follow-up Change of stress MBF in the remote myocardium	0.62 ml/min/g Standard Deviation 0.83	-0.27 ml/min/g Standard Deviation 0.56	—
Myocardial Blood Flow at Baseline and 3-month Follow-up Change of stress MBF in the infarcted myocardium	0.44 ml/min/g Standard Deviation 0.71	0 ml/min/g Standard Deviation 0.46	—

SECONDARY outcome

Timeframe: 3 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Post-infarction Training n=20 Participants 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.	Post-infarction Nontraining n=19 Participants 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.	Healthy Controls n=19 Participants 19 age- and sex-matched healthy volunteers
Angiogenic Cytokines at Baseline and 3-month Follow-up Change of stromal-derived factor-1	-196 pg/ml Standard Deviation 209	-68 pg/ml Standard Deviation 175	-57 pg/ml Standard Deviation 200
Angiogenic Cytokines at Baseline and 3-month Follow-up Change of vascular endothelial growth factor	0.70 pg/ml Standard Deviation 1.41	0.95 pg/ml Standard Deviation 1.46	-1.2 pg/ml Standard Deviation 2.92
Angiogenic Cytokines at Baseline and 3-month Follow-up Change of stem cell factor	20 pg/ml Standard Deviation 120	17 pg/ml Standard Deviation 47	-18 pg/ml Standard Deviation 60

Adverse Events

Postinfarction Training Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Postinfarction Nontraining Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bai-Chin Lee

National Taiwan University Hospital

Phone: 0223123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place