Stem Cells in Myocardial Infarction
|ClinicalTrials.gov Identifier: NCT00135928|
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : August 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)||Phase 2|
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 (1:1) to G-CSF (10 μg/kg/d) 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 microgram/L. Follow-up was done after 1, 5 and 6 months, with an angiogram at 5 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction,|
|Study Start Date :||May 2003|
|Primary Completion Date :||February 2006|
|Study Completion Date :||February 2006|
- The pre-specified primary endpoint is change in regional systolic wall thickening from day 1 to day 180 evaluated with cardiac magnetic resonance imaging (MRI)
- Change in ejection fraction, end-systolic and end-diastolic volumes, regional myocardial perfusion, and infarct size by MRI
- Change in regional myocardial function by tissue Doppler echocardiography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135928
|2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Jens Kastrup, MD DMSc||2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet, DK-2100 Copenhagen, Denmark.|