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Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The 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:
NCT00684021
First received: May 22, 2008
Last updated: June 2, 2015
Last verified: June 2015
Results First Received: January 18, 2013  
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 2008 and November 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
Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.
Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.

Participant Flow:   Overall Study
    Day 3 Stem Cell Arm   Day 3 Placebo Arm   Day 7 Stem Cell Arm   Day 7 Placebo Arm
STARTED   43   24   36   17 
COMPLETED   41   22   34   15 
NOT COMPLETED   2   2   2   2 
MRI Contraindicated                1                1                1                0 
MRI not performed                0                1                1                2 
Death                1                0                0                0 



  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
Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.
Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Total Total of all reporting groups

Baseline Measures
   Day 3 Stem Cell Arm   Day 3 Placebo Arm   Day 7 Stem Cell Arm   Day 7 Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   24   36   17   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.6  (10.8)   57.0  (12.4)   58.2  (11.3)   57.0  (8.0)   56.9  (10.9) 
Gender 
[Units: Participants]
         
Female   5   3   5   2   15 
Male   38   21   31   15   105 
Region of Enrollment 
[Units: Participants]
         
United States   43   24   36   17   120 


  Outcome Measures
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1.  Primary:   Global Left Ventricular Function   [ Time Frame: Measured at Baseline and Month 6 ]

2.  Primary:   Regional Left Ventricular Function (Infarct Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]

3.  Primary:   Regional Left Ventricular Function (Border Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]

4.  Secondary:   Clincal and Safety Outcomes   [ Time Frame: Measured from baseline to six months. ]

5.  Secondary:   Left Ventricular Mass   [ Time Frame: Measured at Baseline and Month 6 ]

6.  Secondary:   End Diastolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]

7.  Secondary:   End Systolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]

8.  Secondary:   Infarct Volume   [ Time Frame: Measured at Baseline and Month 6 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.
Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.

Other Adverse Events
    Day 3 Stem Cell Arm   Day 3 Placebo Arm   Day 7 Stem Cell Arm   Day 7 Placebo Arm
Total, other (not including serious) adverse events         
# participants affected / at risk   10/43 (23.26%)   6/24 (25.00%)   13/36 (36.11%)   6/17 (35.29%) 
Blood and lymphatic system disorders         
Anemia †         
# participants affected / at risk   1/43 (2.33%)   0/24 (0.00%)   0/36 (0.00%)   1/17 (5.88%) 
# events   1   0   0   1 
Cardiac disorders         
Groin bruising/bleeding † [2]         
# participants affected / at risk   5/43 (11.63%)   3/24 (12.50%)   4/36 (11.11%)   4/17 (23.53%) 
# events   6   3   6   5 
Thrombus †         
# participants affected / at risk   1/43 (2.33%)   1/24 (4.17%)   3/36 (8.33%)   0/17 (0.00%) 
# events   1   1   3   0 
General disorders         
Malaise †         
# participants affected / at risk   1/43 (2.33%)   2/24 (8.33%)   4/36 (11.11%)   0/17 (0.00%) 
# events   1   2   4   0 
Nervous system disorders         
Syncope †         
# participants affected / at risk   1/43 (2.33%)   0/24 (0.00%)   2/36 (5.56%)   0/17 (0.00%) 
# events   1   0   2   0 
Respiratory, thoracic and mediastinal disorders         
Bronchitis †         
# participants affected / at risk   1/43 (2.33%)   0/24 (0.00%)   0/36 (0.00%)   1/17 (5.88%) 
# events   1   0   0   1 
Events were collected by systematic assessment
[2] Groin bruising or bleeding at site of catheter insertion



  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
The choice of Day 3 or Day 7 as randomization points while based on the literature were nevertheless somewhat arbitrary. cMR-baseed ejection fractions tended to be high.


  More Information