We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00684060
First Posted: May 26, 2008
Last Update Posted: July 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: April 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Left Ventricular Dysfunction
Interventions: Biological: Adult stem cells
Biological: Placebo

  Participant Flow


  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 
Overall Participants Analyzed 
[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 ]

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:   Combined Endpoint   [ Time Frame: Measured at Baseline and Month 6 ]

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


  Limitations and Caveats


  More Information