Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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

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

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

4.  Secondary:   Combined Endpoint   [ Time Frame: Measured at Baseline and Month 6 ]
  Show Outcome Measure 4

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

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

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Show More Information