Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418418
Status:
UNKNOWN
Last Update Posted:
2008-08-19
First Post:
2007-01-03
Brief Title:
Combined CABG and Stem-Cell Transplantation for Heart Failure
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
Combined CABG and Stem-Cell Transplantation for Heart Failure
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
RECRUITING
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:
This is a prospective double blind trial of intraoperative transmyocardial bone marrow-derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction scheduled to coronary bypass operation
Detailed Description:
The prevalence of symptomatic heart failure in general population is up to 2 and the prevalence increases rapidly with age Half of the patients with symptomatic heart failure will die within 4 years of diagnosisThe purpose of this study is to examine the effect of bone marrow-derived stem cell transplantation in left ventricular ejection fraction
Consecutive patients with systolic heart failure n60 with ischemic coronary heart disease scheduled to by-pass-operation CABG will be collected from cardiovascular laboratory and outpatient clinic of Helsinki University Central Hospital Patients should have heart failure with ejection fraction between 15 to 45 Randomly patients are selected to receive a stem cell transplantation with best possible heart failure medication or without cell transplantation In this study 30 patients are receiving bone marrow transplantation and 30 patients are serving as a control population All patients will receive CABGThe study will be carried out with randomized double blind techniques for one year Randomization in blocks will be based on a table of random numbersBone marrow and patients own serum will be blinded by using colored syringe so that the doctor transfusing the sample will not be able to know the nature of the sample From all patients a right atrial biopsy will be collected for assessment of autologous cardiac stem cells Also sample of pericardial fluid will be collected for measures of growth factors
Comparisons Preoperatively patients will be imagined by cardiac ultrasound cardiac MRI cardiac PET and SPECT Serum pro-BNB samples will be collected Postoperatively at 3 months and 6 months pro-BNB and cardiac ultrasound will be evaluated At one year cardiac ultrasound cardiac MRI cardiac PET and SPECT will be reassessed
Heart failure and coronary artery disease treatments beside the transplantation will be optimized according to the judgment of the doctors of the outpatients clinic Primary endpoint of the study is the change of ejection fraction in MRI images
Consecutive patients with systolic heart failure n60 with ischemic coronary heart disease scheduled to by-pass-operation CABG will be collected from cardiovascular laboratory and outpatient clinic of Helsinki University Central Hospital Patients should have heart failure with ejection fraction between 15 to 45 Randomly patients are selected to receive a stem cell transplantation with best possible heart failure medication or without cell transplantation In this study 30 patients are receiving bone marrow transplantation and 30 patients are serving as a control population All patients will receive CABGThe study will be carried out with randomized double blind techniques for one year Randomization in blocks will be based on a table of random numbersBone marrow and patients own serum will be blinded by using colored syringe so that the doctor transfusing the sample will not be able to know the nature of the sample From all patients a right atrial biopsy will be collected for assessment of autologous cardiac stem cells Also sample of pericardial fluid will be collected for measures of growth factors
Comparisons Preoperatively patients will be imagined by cardiac ultrasound cardiac MRI cardiac PET and SPECT Serum pro-BNB samples will be collected Postoperatively at 3 months and 6 months pro-BNB and cardiac ultrasound will be evaluated At one year cardiac ultrasound cardiac MRI cardiac PET and SPECT will be reassessed
Heart failure and coronary artery disease treatments beside the transplantation will be optimized according to the judgment of the doctors of the outpatients clinic Primary endpoint of the study is the change of ejection fraction in MRI images
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