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: April 2, 2013

Last verified: April 2013

History of Changes

Results First Received: January 18, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, 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 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
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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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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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3. Primary:

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

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4. Secondary:

Clincal and Safety Outcomes [ Time Frame: Measured from baseline to six months. ]

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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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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
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.

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