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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
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Granulocyte Colony Stimulating Factor G-CSF (Neupogen®) Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Change in ejection fraction, end-systolic and end-diastolic volumes, regional myocardial perfusion, and infarct size by MRI
  2. Change in regional myocardial function by tissue Doppler echocardiography


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00135928     History of Changes
Other Study ID Numbers: STEMMI
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: February 2005

Keywords provided by Rigshospitalet, Denmark:
ST-elevation myocardial infarction
granulocyte-colony stimulating factor angiogenesis
stem cells

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs