Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00824005
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2009-01-15
Brief Title:
Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy The FOCUS Study
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Randomized Controlled Phase II Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Patients With Chronic Ischemic Heart Disease and Left Ventricular Dysfunction
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease CAD is a common disorder that can lead to heart failure Not all people with CAD are eligible for todays standard treatments One new treatment approach uses stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart This study will determine the safety and effectiveness of withdrawing stem cells from someones bone marrow and injecting those cells into the persons heart as a way of treating people with CAD and heart failure
Detailed Description:
Coronary artery disease CAD a disease in which blood vessels become clogged by a build-up of plaque is the leading cause of heart failure a condition in which the heart can no longer pump enough blood to the rest of the body People with heart failure caused by CAD are said to have ischemic cardiomyopathy Normal treatment for CAD involves coronary artery bypass grafting in which a vein from another part of the body is grafted around an artery that has become blocked or coronary angioplasty and stent placement in which a blocked artery is opened and a small tube is placed to keep the artery open However some people with ischemic cardiomyopathy such as those with substantial scar tissue on the heart wall or those with a particular heart structure may not be eligible for these treatments An alternative treatment being developed is therapeutic angiogenesis which involves stimulating the growth of new blood vessels Recent research has shown that withdrawing stem cells from bone marrow and implanting the cells into heart tissue may be an effective way to achieve therapeutic angiogenesis This study will determine the safety and effectiveness of using stem cells to stimulate new blood vessel growth in the hearts of people with ischemic cardiomyopathy
Participation in this study including follow-up visits and phone calls will last 60 months Participants will first undergo 3 to 4 days of screening procedures that will include a physical examination multiple lab tests and a battery of tests on heart health Next participants will be randomized to receive either active stem cell injections or placebo injections The injections and related procedures will be performed in a hospital and last approximately 72 hours During this time participants in both groups will first undergo a bone marrow aspiration procedure Participants receiving active stem cells will also undergo NOGA electromechanical cardiac mapping which involves inserting a monitoring device through a catheter and into the heart Injections of stem cells will then be made to 15 damaged sites on the heart through a special catheter Participants receiving placebo injections will receive 15 injections of an inactive saline-based solution After the injection procedures all participants will undergo two echocardiograms an electrocardiogram blood tests and overnight monitoring in a telemetry unit
After the hospital stay all participants will attend five study visits that will occur 1 week and 1 3 6 and 12 months after the injection procedures At all study visits participants will undergo an electrocardiogram lab tests and a review of adverse health events On all but the last study visit participants will have cardiac markers assessed and they will wear a 24-hour Holter monitor to track heart activity At the last three visits participants will also complete quality of life questionnaires All participants will then receive four follow-up telephone calls that will occur 2 3 4 and 5 years after the injection procedures
Participation in this study including follow-up visits and phone calls will last 60 months Participants will first undergo 3 to 4 days of screening procedures that will include a physical examination multiple lab tests and a battery of tests on heart health Next participants will be randomized to receive either active stem cell injections or placebo injections The injections and related procedures will be performed in a hospital and last approximately 72 hours During this time participants in both groups will first undergo a bone marrow aspiration procedure Participants receiving active stem cells will also undergo NOGA electromechanical cardiac mapping which involves inserting a monitoring device through a catheter and into the heart Injections of stem cells will then be made to 15 damaged sites on the heart through a special catheter Participants receiving placebo injections will receive 15 injections of an inactive saline-based solution After the injection procedures all participants will undergo two echocardiograms an electrocardiogram blood tests and overnight monitoring in a telemetry unit
After the hospital stay all participants will attend five study visits that will occur 1 week and 1 3 6 and 12 months after the injection procedures At all study visits participants will undergo an electrocardiogram lab tests and a review of adverse health events On all but the last study visit participants will have cardiac markers assessed and they will wear a 24-hour Holter monitor to track heart activity At the last three visits participants will also complete quality of life questionnaires All participants will then receive four follow-up telephone calls that will occur 2 3 4 and 5 years after the injection procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1 U01-HL-087318-01 Project 3 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01HL087318 |
| U01HL087318 | NIH | None | None |