Stem Cells in Myocardial Infarction

Phase 2

Completed

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00135928
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2003-05
• Status Verified: 2005-02
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark