Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135928
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2005-08-25
Brief Title:
Stem Cells in Myocardial Infarction
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2005-02
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:
The purpose of this trial is to investigate the effect of treatment with granulocyte-colony stimulating factor G-CSF bone marrow stimulation on circulating stem cells ability to develop new blood vessels in the myocardium after an acute myocardial infarction
Detailed Description:
Intracoronary infusion of bone-marrow stem cells after a ST elevation myocardial infarction STEMI seems to improve cardiac function An alternative strategy is increase of circulating stem cells by mobilisation from the bone marrow with Granulocyte-Colony Stimulating Factor G-CSF
Objective To determine the short-term 30 days safety of G-CSF therapy after a STEMI treated with acute percutaneous coronary intervention PCI
Methods Patients with STEMI treated with PCI 12 hours after symptom onset were randomised 11 to G-CSF 10 μgkgd or placebo for 6 days in a double-blind design Other inclusion criteria age 20-70 years culprit lesion in a large coronary artery and peak CKMB 100 microgramL Follow-up was done after 1 5 and 6 months with an angiogram at 5 months
Objective To determine the short-term 30 days safety of G-CSF therapy after a STEMI treated with acute percutaneous coronary intervention PCI
Methods Patients with STEMI treated with PCI 12 hours after symptom onset were randomised 11 to G-CSF 10 μgkgd or placebo for 6 days in a double-blind design Other inclusion criteria age 20-70 years culprit lesion in a large coronary artery and peak CKMB 100 microgramL Follow-up was done after 1 5 and 6 months with an angiogram at 5 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