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: July 7, 2015

Last verified: July 2015

History of Changes

Results First Received: April 9, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Left Ventricular Dysfunction
Interventions:	Biological: Adult stem cells Biological: Placebo

Participant Flow

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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
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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

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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.
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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

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1. Primary:

Global Left Ventricular Function [ Time Frame: Measured at Baseline and Month 6 ]

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2. Primary:

Regional Left Ventricular Function (Infarct Zone Wall Motion) [ Time Frame: Measured at Baseline and Month 6 ]

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Measure Type	Primary
Measure Title	Regional Left Ventricular Function (Infarct Zone Wall Motion)
Measure 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

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.
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.

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.

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.

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.

Measured Values

	Stem Cell Arm	Placebo Arm
Participants Analyzed [Units: Participants]	55	25
Regional Left Ventricular Function (Infarct Zone Wall Motion) [Units: Mm] Mean (Standard Deviation)	0.3 (4.3)	1.0 (4.5)

Statistical Analysis 1 for Regional Left Ventricular Function (Infarct Zone Wall Motion)

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	t-test, 2 sided
P Value ^[4]	<0.05
Mean Difference (Net) ^[5]	-0.7
95% Confidence Interval	-2.8 to 1.3
Standard Error of the mean	(4.4)

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results
[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:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	No text entered.

3. Primary:

Regional Left Ventricular Function (Border Zone Wall Motion) [ Time Frame: Measured at Baseline and Month 6 ]

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4. Secondary:

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

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5. Secondary:

Left Ventricular Mass [ Time Frame: Measured at Baseline and Month 6 ]

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6. Secondary:

End Diastolic Volume Index [ Time Frame: Measured at Baseline and Month 6 ]

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7. Secondary:

End Systolic Volume Index [ Time Frame: Measured at Baseline and Month 6 ]

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Measure Type	Secondary
Measure Title	End Systolic Volume Index
Measure 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

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.
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.

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.

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.

Measured Values

	Stem Cell Arm	Placebo Arm
Participants Analyzed [Units: Participants]	55	26
End Systolic Volume Index [Units: mL/m2] Mean (Standard Deviation)	0.2 (14.0)	-2.3 (14.7)

Statistical Analysis 1 for End Systolic Volume Index

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	t-test, 2 sided
P Value ^[4]	<0.05
Mean Difference (Net) ^[5]	2.5
95% Confidence Interval	-4.1 to 9.2
Standard Error of the mean	(14.2)

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of change in the active group minus change in the control group.
[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:
	No text entered.
[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.

8. Secondary:

Infarct Volume [ Time Frame: Measured at Baseline and Month 6 ]

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Serious Adverse Events

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Other Adverse Events

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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
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.

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