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NCT00684021 · ClinicalTrials.gov registry record · Phase 2
Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)
A Phase 2 study of Left Ventricular Dysfunction, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 5
- Study locations
NCT00684021: Completed Phase 2 study of Left Ventricular Dysfunction, sponsored by The University of Texas Health Science Center, Houston.
NCT00684021 is a Phase 2 study of Left Ventricular Dysfunction that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 120 participants, below the 1,221-participant average among 7 other Left Ventricular Dysfunction trials with a reported enrollment target (90% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00684021, a Phase 2 study of Left Ventricular Dysfunction, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 5
- Study locations
Study Summary
Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blocked almost completely and the heart muscle in that area can suffer permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function after a heart attack. This study will evaluate the safety and effectiveness of using adult stem cells for improving heart function in people who have had a recent heart attack and a PCI.
Primary Outcome
Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Adult stem cells
Study Locations (5)
Florida
- University of Florida-Department of Medicine - Gainesville
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
Ohio
- Cleveland Clinic - Cleveland
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- Texas Heart Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00684021 record still lists
NCT00684021 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,221-participant average among 7 other Left Ventricular Dysfunction trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Left Ventricular Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00684021 lists 5 locations in 5 states (Florida, Minnesota, Ohio).
Frequently Asked Questions
What is clinical trial NCT00684021 about?
NCT00684021 is a clinical study titled "Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)". Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blo...
What is the current status of trial NCT00684021?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2008-07. Estimated completion is 2012-11.
What conditions does trial NCT00684021 study?
This clinical trial studies the following conditions: Left Ventricular Dysfunction.
What interventions are being tested in trial NCT00684021?
The interventions under investigation include: Placebo (BIOLOGICAL), Adult stem cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00684021?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00684021 being conducted?
This trial has 5 study locations across Florida, Minnesota, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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