Stem Cells in Myocardial Infarction - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)	Phase II

MedlinePlus related topics:

Heart Attack

ChemIDplus related topics:

Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction,

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	78
Study Start Date:	May 2003
Estimated Study Completion Date:	February 2006

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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135928

Locations


Denmark
	2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
	Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators


Principal Investigator:	Jens Kastrup, MD DMSc	2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet, DK-2100 Copenhagen, Denmark.

More Information

Study ID Numbers:	STEMMI
First Received:	August 25, 2005
Last Updated:	December 7, 2005
ClinicalTrials.gov Identifier:	NCT00135928
Health Authority:	Denmark: Danish Medicines Agency