Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00820586
Status:
SUSPENDED
Last Update Posted:
2012-02-02
First Post:
2009-01-08
Brief Title:
Intramyocardial Delivery of Autologous Bone Marrow
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Intramyocardial Delivery of Autologous Bone Marrow
Status:
SUSPENDED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No more funding support for additional procedures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized study to assess the safety feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34 cells in patients with refractory angina pectoris
Detailed Description:
Primary Endpoint Incidence of major adverse cardiac events MACE at 30 days MACE is defined as a combined endpoint of death acute MI Q-wave and non-Q wave revascularization procedures percutaneous or surgical and peri-procedural complications that is left ventricular perforation with hemodynamic consequences requiring pericardiocentesis and stroke
Incidence of MACE at 3 6 and 12 months
Secondary Endpoints
Change in Canadian Cardiovascular Society CCS angina classification score from baseline to 12 months
Changes in the quality of life as assessed according to the Seattle Angina Questionnaire
Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline to 6 months and to 12 months
Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment
SPECT-chances in global and regional radionuclide perfusion at rest peak stress and redistribution for baseline to 1 6 and 12 months
Change in angiographic collateral score at 6 months
Change in global and regional myocardial contractility assessed by echocardiography at baseline 6 and 12 months
Incidence of MACE at 3 6 and 12 months
Secondary Endpoints
Change in Canadian Cardiovascular Society CCS angina classification score from baseline to 12 months
Changes in the quality of life as assessed according to the Seattle Angina Questionnaire
Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline to 6 months and to 12 months
Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment
SPECT-chances in global and regional radionuclide perfusion at rest peak stress and redistribution for baseline to 1 6 and 12 months
Change in angiographic collateral score at 6 months
Change in global and regional myocardial contractility assessed by echocardiography at baseline 6 and 12 months
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