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Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00684060
First received: May 22, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
Results First Received: April 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Left Ventricular Dysfunction
Interventions: Biological: Adult stem cells
Biological: Placebo

  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
Enrollment took place at five Network centers and their associated satellite facilities between July 8, 2008 and February 28, 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Participant Flow:   Overall Study
    Stem Cell Arm     Placebo Arm  
STARTED     58     29  
COMPLETED     55     26  
NOT COMPLETED     3     3  
Lost to Follow-up                 1                 0  
New stenosis identified                 1                 0  
Unable to collect MRI                 1                 2  
Death                 0                 1  



  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
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Total Total of all reporting groups

Baseline Measures
    Stem Cell Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
 		  58     29     87  
Age  
[units: years]
Mean ± Standard Deviation 		  57.6  ± 11     54.6  ± 11     57  ± 11  
Gender  
[units: participants]
 		     
Female     12     3     15  
Male     46     26     72  
Region of Enrollment  
[units: participants]
 		     
United States     58     29     87  



  Outcome Measures
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1.  Primary:   Global Left Ventricular Function   [ Time Frame: Measured at Baseline and Month 6 ]
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Measure Type Primary
Measure Title Global Left Ventricular Function
Measure Description Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.
Time Frame Measured at Baseline and Month 6  
Safety Issue No  

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.

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in Global EF from baseline to six months.

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Measured Values
    Stem Cell Arm     Placebo Arm  
Number of Participants Analyzed  
[units: participants]
 		  55     26  
Global Left Ventricular Function  
[units: percentage of ejection fraction]
Mean ± Standard Deviation 		  0.5  ± 8.2     3.6  ± 9.3  


Statistical Analysis 1 for Global Left Ventricular Function
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] <0.05
Mean Difference (Net) [4] -3.0
Standard Error of the mean ± 8.6
95% Confidence Interval ( -7.05 to .95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No adjustment for multiple comparisons
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Threshold 0.05
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   Regional Left Ventricular Function (Infarct Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]
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3.  Primary:   Regional Left Ventricular Function (Border Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]
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4.  Secondary:   Combined Endpoint   [ Time Frame: Measured at Baseline and Month 6 ]
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5.  Secondary:   Left Ventricular Mass   [ Time Frame: Measured at Baseline and Month 6 ]
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6.  Secondary:   End Diastolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]
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Measure Type Secondary
Measure Title End Diastolic Volume Index
Measure Description Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.
Time Frame Measured at Baseline and Month 6  
Safety Issue No  

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.

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in LV end diastolic index from baseline to six months.

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Measured Values
    Stem Cell Arm     Placebo Arm  
Number of Participants Analyzed  
[units: participants]
 		  55     26  
End Diastolic Volume Index  
[units: mL/m2]
Mean ± Standard Deviation 		  3.4  ± 23.4     2.7  ± 18.1  


Statistical Analysis 1 for End Diastolic Volume Index
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] <0.05
Mean Difference (Net) [4] 0.7
Standard Error of the mean ± 21.8
95% Confidence Interval ( -9.5 to 10.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of change in the active group minus change in global LVEF in the control group.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   End Systolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]
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8.  Secondary:   Infarct Volume   [ Time Frame: Measured at Baseline and Month 6 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
Lack of in-vivo testing of cell product. While there are several different approaches to measure myocardial strain (myocardial tagging, DENSE, etc.), these were not employed in this study due to the need for specialized expertise at each site.


  More Information
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