Trial Outcomes & Findings for Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study) (NCT NCT00684060)
NCT ID: NCT00684060
Last Updated: 2015-07-10
Results Overview
Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.
COMPLETED
PHASE2
87 participants
Measured at Baseline and Month 6
2015-07-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
29
|
|
Overall Study
COMPLETED
|
55
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
New stenosis identified
|
1
|
0
|
|
Overall Study
Unable to collect MRI
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
Baseline characteristics by cohort
| Measure |
Stem Cell Arm
n=58 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=29 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 11 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 11 • n=7 Participants
|
57 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
29 participants
n=7 Participants
|
87 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and Month 6Population: 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.
Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.
Outcome measures
| Measure |
Stem Cell Arm
n=55 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=26 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Global Left Ventricular Function
|
0.5 percentage of ejection fraction
Standard Deviation 8.2
|
3.6 percentage of ejection fraction
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: Measured at Baseline and Month 6Population: Only participants with both baseline and 6 month MRI images available are included. One patient was excluded from the analysis due to incomplete signal intensity enhancement data. Values reported represent the change in wall motion over time in the infarct zone from baseline to six months.
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.
Outcome measures
| Measure |
Stem Cell Arm
n=55 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=25 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Regional Left Ventricular Function (Infarct Zone Wall Motion)
|
0.3 mm
Standard Deviation 4.3
|
1.0 mm
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Measured at Baseline and Month 6Population: Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4). Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.
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.
Outcome measures
| Measure |
Stem Cell Arm
n=53 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=23 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Regional Left Ventricular Function (Border Zone Wall Motion)
|
0.5 mm
Standard Deviation 7.2
|
3.2 mm
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Measured at Baseline and Month 6Population: All randomized patients were followed for clinical outcomes. However the paucity of events precluded a reliable time to event analysis.
Combined endpoint: first of death, reinfarction, repeat revascularization, and hospitalization for heart failure. This is measured as the number of events by treatment group over the 6 month follow up period.
Outcome measures
| Measure |
Stem Cell Arm
n=58 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=29 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Combined Endpoint
|
3 events
|
4 events
|
SECONDARY outcome
Timeframe: Measured at Baseline and Month 6Population: 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.
Left ventricular mass (LV mass. Values reported represent the change in LV mass from baseline to six months.)
Outcome measures
| Measure |
Stem Cell Arm
n=55 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=26 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Left Ventricular Mass
|
-12.0 g
Standard Deviation 18.1
|
-10.8 g
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Measured at Baseline and Month 6Population: 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.
Left ventricular end diastolic volume index. Values reported represent the change in LV end diastolic index from baseline to six months.
Outcome measures
| Measure |
Stem Cell Arm
n=55 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=26 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
End Diastolic Volume Index
|
3.4 mL/m2
Standard Deviation 23.4
|
2.7 mL/m2
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Measured at Baseline and Month 6Population: 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.
Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index from baseline to six months.
Outcome measures
| Measure |
Stem Cell Arm
n=55 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=26 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
End Systolic Volume Index
|
0.2 mL/m2
Standard Deviation 14.0
|
-2.3 mL/m2
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Measured at Baseline and Month 6Population: 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.
Infarct volume(mL). Values reported represent the change in infarct volume from baseline to six months.
Outcome measures
| Measure |
Stem Cell Arm
n=55 Participants
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=25 Participants
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Infarct Volume
|
-3.5 mL
Standard Deviation 19.0
|
-2.0 mL
Standard Deviation 14.4
|
Adverse Events
Stem Cell Arm
Placebo Arm
Serious adverse events
| Measure |
Stem Cell Arm
n=58 participants at risk
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=29 participants at risk
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
10.3%
6/58 • Number of events 9 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
27.6%
8/29 • Number of events 8 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Cardiac disorders
Heart Failure
|
3.4%
2/58 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
6.9%
2/29 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Cardiac disorders
Left Ventricular Thrombus
|
0.00%
0/58 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
6.9%
2/29 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/58 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
6.9%
2/29 • Number of events 3 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
Other adverse events
| Measure |
Stem Cell Arm
n=58 participants at risk
Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
|
Placebo Arm
n=29 participants at risk
Participants will receive placebo infusion (5% human serum albumin \[HSA\]) 2 to 3 weeks after a PCI.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
1.7%
1/58 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
10.3%
3/29 • Number of events 3 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Cardiac disorders
Chest Pain
|
6.9%
4/58 • Number of events 5 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
13.8%
4/29 • Number of events 4 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/58 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
10.3%
3/29 • Number of events 3 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Gastrointestinal disorders
Nausea
|
5.2%
3/58 • Number of events 3 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
0.00%
0/29 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Blood and lymphatic system disorders
Anemia
|
6.9%
4/58 • Number of events 4 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
6.9%
2/29 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
|
Cardiac disorders
Syncope
|
1.7%
1/58 • Number of events 1 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
6.9%
2/29 • Number of events 2 • Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
|
Additional Information
Lemuel Moye, MD, PhD
UT-Houston School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place