NCT00135928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 8, 2011

Status Verified

February 1, 2005

Enrollment Period

2.8 years

First QC Date

August 25, 2005

Last Update Submit

August 4, 2011

Conditions

Acute Myocardial Infarction

Keywords

ST-elevation myocardial infarctiongranulocyte-colony stimulating factor angiogenesisstem cells

Outcome Measures

Primary Outcomes (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 Outcomes (2)

  • 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

Interventions

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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • Ripa RS, Jorgensen E, Kastrup J. Clinical outcome after stem cell mobilization with granulocyte-colony-stimulating factor after acute ST-elevation myocardial infarction: 5-year results of the STEMMI trial. Scand J Clin Lab Invest. 2013 Mar;73(2):125-9. doi: 10.3109/00365513.2012.750010. Epub 2013 Jan 3.

    PMID: 23281844DERIVED

  • Hedegaard A, Ripa RS, Johansen JS, Jorgensen E, Kastrup J. Plasma YKL-40 and recovery of left ventricular function after acute myocardial infarction. Scand J Clin Lab Invest. 2010 Apr;70(2):80-6. doi: 10.3109/00365510903518191.

    PMID: 20102300DERIVED

  • Overgaard M, Ripa RS, Wang Y, Jorgensen E, Kastrup J. Timing of granulocyte-colony stimulating factor treatment after acute myocardial infarction and recovery of left ventricular function: results from the STEMMI trial. Int J Cardiol. 2010 Apr 30;140(3):351-5. doi: 10.1016/j.ijcard.2008.11.120. Epub 2009 Jan 7.

    PMID: 19131132DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jens Kastrup, MD DMSc

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

May 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

August 8, 2011

Record last verified: 2005-02

Locations

DK(1)