Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362388
Status:
TERMINATED
Last Update Posted:
2010-01-27
First Post:
2006-08-08
Brief Title:
Cell Therapy in Chronic Ischemic Heart Disease
Sponsor:
Ministry of Health Brazil
Organization:
Ministry of Health Brazil
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
Status:
TERMINATED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollling
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels ameliorating the hearts performance and relieving patients from symptoms like angina andor shortness of breath
Detailed Description:
Severe ischemic heart disease IHD remains a clinical challenge many patients with IHD have undergone myocardial revascularization procedures either percutaneous or surgical but still remain symptomatic despite maximally tolerated medical therapy Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease
Cell therapy with autologous bone marrow-derived cells BMC is a novel therapeutic strategy being tested for many cardiovascular diseases including heart failure acute myocardial infarction chronic ischemic heart disease
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy compared to placebo in patients undergoing coronary artery bypass surgery CABG
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class anginaheart failure functional capacity global and cardiovascular mortality and quality of life in patients undergoing coronary artery bypass surgery CABG
Cell therapy with autologous bone marrow-derived cells BMC is a novel therapeutic strategy being tested for many cardiovascular diseases including heart failure acute myocardial infarction chronic ischemic heart disease
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy compared to placebo in patients undergoing coronary artery bypass surgery CABG
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class anginaheart failure functional capacity global and cardiovascular mortality and quality of life in patients undergoing coronary artery bypass surgery CABG
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