Stem Cells in Myocardial Infarction
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|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)|
|Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction,|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||February 2006|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|