Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)

NCT00126100 | Completed Phase 4 DMC

• 3 other identifiers: GE IDE No. I01003KKF 10-02KKF 04-03
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.

Conditions

Myocardial Infarction

Keywords

Stem Cells

Outcome Measures

Primary Outcomes (1)

• Reduction of infarct size (measured by Tc-sestamibi scintigraphy)

  measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months

Secondary Outcomes (2)

• Left ventricular ejection fraction

  Left ventricular ejection fraction

• Incidence of angiographic restenosis

  6 months

Study Arms (2)

1

EXPERIMENTAL

Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.

Drug: G-CSF Granulocyte-Colony Stimulating Factor

2

PLACEBO COMPARATOR

Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.

Other: Placebo

Interventions

G-CSF Granulocyte-Colony Stimulating Factor DRUG

Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.

Also known as: Neupogen (Filograstim), Granocyte (Lenograstim)

1

Placebo OTHER

Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ST-elevation acute myocardial infarction (5 days before randomization)
• Successful percutaneous coronary intervention \[PCI\] (performed within 12 hours from symptom onset)
• Scintigraphic infarct size \>5% of left ventricle
• Written informed consent

You may not qualify if:

• Age \<18 years or \>80 years
• Congestive heart failure defined as Killip class \>2
• A history of myocardial infarction
• Electrical or hemodynamic instability
• Autoimmune diseases
• Fructose intolerance
• Malignancies
• Incompatibility of filgrastim
• Known or suspected pregnancy

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead
• Wilhelm Sander Foundation: collaborator
• Schulz Foundation: collaborator
• Else Kröner Fresenius Foundation: collaborator

Study Sites (2)

Deutsches Herzzentrum

Munich, 80636, Germany

Location

671. Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (4)

• Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I, Quaini F, Nadal-Ginard B, Bodine DM, Leri A, Anversa P. Mobilized bone marrow cells repair the infarcted heart, improving function and survival. Proc Natl Acad Sci U S A. 2001 Aug 28;98(18):10344-9. doi: 10.1073/pnas.181177898. Epub 2001 Aug 14.

  PMID: 11504914 BACKGROUND

• Kocher AA, Schuster MD, Szabolcs MJ, Takuma S, Burkhoff D, Wang J, Homma S, Edwards NM, Itescu S. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function. Nat Med. 2001 Apr;7(4):430-6. doi: 10.1038/86498.

  PMID: 11283669 BACKGROUND

• Harada M, Qin Y, Takano H, Minamino T, Zou Y, Toko H, Ohtsuka M, Matsuura K, Sano M, Nishi J, Iwanaga K, Akazawa H, Kunieda T, Zhu W, Hasegawa H, Kunisada K, Nagai T, Nakaya H, Yamauchi-Takihara K, Komuro I. G-CSF prevents cardiac remodeling after myocardial infarction by activating the Jak-Stat pathway in cardiomyocytes. Nat Med. 2005 Mar;11(3):305-11. doi: 10.1038/nm1199. Epub 2005 Feb 20.

  PMID: 15723072 BACKGROUND

• Zohlnhofer D, Ott I, Mehilli J, Schomig K, Michalk F, Ibrahim T, Meisetschlager G, von Wedel J, Bollwein H, Seyfarth M, Dirschinger J, Schmitt C, Schwaiger M, Kastrati A, Schomig A; REVIVAL-2 Investigators. Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: a randomized controlled trial. JAMA. 2006 Mar 1;295(9):1003-10. doi: 10.1001/jama.295.9.1003.

  PMID: 16507801 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Filgrastim; Lenograstim

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Albert Schomig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2005
• First Posted: August 2, 2005
• Study Start: February 1, 2004
• Study Completion: July 1, 2005
• Last Updated: November 26, 2007

Record last verified: 2007-11

Locations

DE (2)