Acute Myocardial Infarction
Conditions
Keywords
ST-elevation myocardial infarction, granulocyte-colony stimulating factor angiogenesis, stem cells
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 (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.
Interventions
DRUGGranulocyte Colony Stimulating Factor G-CSF (Neupogen®)
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 20 and 70 years with STEMI were eligible if they had a successful PCI within 12 hours after onset of symptoms. * The target lesion had to be located in the proximal section of the left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA). * Only patients with creatine kinase \[CK\]-MB \>100 microgram/L or development of Q waves in the electrocardiogram were included.
Exclusion criteria
* Ventricular arrhythmia after PCI requiring treatment * Pregnancy * Unprotected left main stem lesion * History of prior myocardial infarction * Diagnosed or suspected cancer * New York Heart Association (NYHA) class 3-4 * Known severe claustrophobia * Significant stenosis in another coronary vessel than the acutely treated vessel, that might demand treatment with PCI or coronary artery bypass graft surgery (CABG) prior to the last follow-up exam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Outcome results
None listed