Stem Cells in Myocardial Infarction

Rigshospitalet, Denmark78 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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