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Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)

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.
ClinicalTrials.gov Identifier: NCT00684021
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : April 4, 2013
Last Update Posted : June 30, 2015
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

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
Enrollment 120
Recruitment Details 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  
Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. Participants will receive active adult stem cell infusion 7 days after PCI. Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Period Title: Overall Study
Started 43 24 36 17
Completed 41 22 34 15
Not Completed 2 2 2 2
Reason Not Completed
MRI Contraindicated             1             1             1             0
MRI not performed             0             1             1             2
Death             1             0             0             0
Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm Total
Hide Arm/Group Description Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. Participants will receive active adult stem cell infusion 7 days after PCI. Participants will receive placebo infusion (5% HSA) 7 days after PCI. Total of all reporting groups
Overall Number of Baseline Participants 43 24 36 17 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 24 participants 36 participants 17 participants 120 participants
55.6  (10.8) 57.0  (12.4) 58.2  (11.3) 57.0  (8.0) 56.9  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 24 participants 36 participants 17 participants 120 participants
Female
5
  11.6%
3
  12.5%
5
  13.9%
2
  11.8%
15
  12.5%
Male
38
  88.4%
21
  87.5%
31
  86.1%
15
  88.2%
105
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 24 participants 36 participants 17 participants 120 participants
43 24 36 17 120
1.Primary Outcome
Title Global Left Ventricular Function
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 41 22 34 15
Mean (Standard Deviation)
Unit of Measure: percentage of ejection fraction
3.5  (11.0) 4.4  (10.6) 2.8  (9.7) 1.7  (8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.959
Comments [Not Specified]
Method t-test, 2 sided
Comments Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-4.1 to 3.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Regional Left Ventricular Function (Infarct Zone Wall Motion)
Hide Description One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only participants with both baseline and 6 month MRI images available are included. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.
Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 41 22 34 15
Mean (Standard Deviation)
Unit of Measure: mm
2.1  (5.9) 2.4  (5.3) 1.2  (4.9) 2.8  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.409
Comments [Not Specified]
Method t-test, 2 sided
Comments Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-3.0 to 1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 100
Confidence Interval (2-Sided) 95%
15 to 1000
Parameter Dispersion
Type: Standard Error of the mean
Value: .01
Estimation Comments [Not Specified]
3.Primary Outcome
Title Regional Left Ventricular Function (Border Zone Wall Motion)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.
Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 41 22 34 15
Mean (Standard Deviation)
Unit of Measure: mm
3.5  (9.3) 4.3  (8.7) 4.2  (8.3) 4.4  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.777
Comments [Not Specified]
Method t-test, 2 sided
Comments Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-3.9 to 2.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Clincal and Safety Outcomes
Hide Description Number of events -death, reinfarction, repeat revascularizations (target and nontarget vessels) hospitalizations for heart failure, ICD placements
Time Frame Measured from baseline to six months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were followed for clinical outcomes.
Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 43 24 36 17
Measure Type: Number
Unit of Measure: events
10 9 6 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.42 to 2.23
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Left Ventricular Mass
Hide Description Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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

Values reported represent the change in LV mass from baseline to six months.

Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 40 22 33 13
Mean (Standard Deviation)
Unit of Measure: g
-20.4  (22.8) -13.2  (30.6) -16.3  (16.7) -20.7  (26.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-12.2 to 6.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title End Diastolic Volume Index
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 41 22 34 15
Mean (Standard Deviation)
Unit of Measure: mL/m2
11.4  (18.5) 11.7  (19.8) 13.3  (19.5) 9.7  (16.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.831
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-6.6 to 8.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title End Systolic Volume Index
Hide Description Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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

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

Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 41 22 34 15
Mean (Standard Deviation)
Unit of Measure: mL/m2
4.1  (15.0) 4.1  (16.5) 6.2  (17.4) 4.6  (12.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-5.5 to 7.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Infarct Volume
Hide Description Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.
Time Frame Measured at Baseline and Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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

Values reported represent the change in infarct volume from baseline to six months.

Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description:
Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Participants will receive active adult stem cell infusion 7 days after PCI.
Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Overall Number of Participants Analyzed 40 20 32 13
Mean (Standard Deviation)
Unit of Measure: mL
-9.7  (18.4) -7.7  (23.4) -13.6  (18.8) -5.3  (29.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Day 3 Stem Cell Arm, Day 3 Placebo Arm, Day 7 Stem Cell Arm, Day 7 Placebo Arm
Comments Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.272
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.7
Confidence Interval (2-Sided) 95%
-13.7 to 3.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.27
Estimation Comments [Not Specified]
Time Frame Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Hide Arm/Group Description Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI). Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI. Participants will receive active adult stem cell infusion 7 days after PCI. Participants will receive placebo infusion (5% HSA) 7 days after PCI.
All-Cause Mortality
Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/43 (39.53%)      6/24 (25.00%)      11/36 (30.56%)      2/17 (11.76%)    
Cardiac disorders         
Chest Pain   8/43 (18.60%)  9 2/24 (8.33%)  2 1/36 (2.78%)  1 0/17 (0.00%)  0
Angina   2/43 (4.65%)  2 0/24 (0.00%)  0 2/36 (5.56%)  2 0/17 (0.00%)  0
Heart Failure   4/43 (9.30%)  4 1/24 (4.17%)  1 0/36 (0.00%)  0 0/17 (0.00%)  0
New/Worsening Thrombus   1/43 (2.33%)  1 2/24 (8.33%)  2 5/36 (13.89%)  5 1/17 (5.88%)  1
Coronary Artery Disease   1/43 (2.33%)  1 0/24 (0.00%)  0 2/36 (5.56%)  2 0/17 (0.00%)  0
Cardiomyopathy   1/43 (2.33%)  1 1/24 (4.17%)  1 1/36 (2.78%)  1 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Day 3 Stem Cell Arm Day 3 Placebo Arm Day 7 Stem Cell Arm Day 7 Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/43 (23.26%)      6/24 (25.00%)      13/36 (36.11%)      6/17 (35.29%)    
Blood and lymphatic system disorders         
Anemia   1/43 (2.33%)  1 0/24 (0.00%)  0 0/36 (0.00%)  0 1/17 (5.88%)  1
Cardiac disorders         
Groin bruising/bleeding  [1]  5/43 (11.63%)  6 3/24 (12.50%)  3 4/36 (11.11%)  6 4/17 (23.53%)  5
Thrombus   1/43 (2.33%)  1 1/24 (4.17%)  1 3/36 (8.33%)  3 0/17 (0.00%)  0
General disorders         
Malaise   1/43 (2.33%)  1 2/24 (8.33%)  2 4/36 (11.11%)  4 0/17 (0.00%)  0
Nervous system disorders         
Syncope   1/43 (2.33%)  1 0/24 (0.00%)  0 2/36 (5.56%)  2 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchitis   1/43 (2.33%)  1 0/24 (0.00%)  0 0/36 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
[1]
Groin bruising or bleeding at site of catheter insertion
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
Phone: 713-500-9518
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00684021     History of Changes
Other Study ID Numbers: 579
U01HL087318 ( U.S. NIH Grant/Contract )
1 U01-HL-087318-01 (Project 1)
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: January 18, 2013
Results First Posted: April 4, 2013
Last Update Posted: June 30, 2015