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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;   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
  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 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
  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 ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Regional Left Ventricular Function (Border Zone Wall Motion)
Measure Description Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.
Time Frame Measured at Baseline and Month 6  

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.
Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.

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.

Measured Values
   Day 3 Stem Cell Arm   Day 3 Placebo Arm   Day 7 Stem Cell Arm   Day 7 Placebo Arm 
Participants Analyzed 
[Units: Participants]
 41   22   34   15 
Regional Left Ventricular Function (Border Zone Wall Motion) 
[Units: Mm]
Mean (Standard Deviation)
 3.5  (9.3)   4.3  (8.7)   4.2  (8.3)   4.4  (7.2) 


Statistical Analysis 1 for Regional Left Ventricular Function (Border Zone Wall Motion)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] 0.777
Mean Difference (Net) [5] -0.5
95% Confidence Interval -3.9 to 2.9
Standard Error of the mean (1.7)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.
[4] 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.
[5] Other relevant estimation information:
  No text entered.



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


  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