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

Sponsor:	Deutsches Herzzentrum Muenchen
Collaborators:	Wilhelm Sander Foundation Schulz Foundation Else Kröner Fresenius Foundation
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00126100

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Drug: G-CSF Granulocyte-Colony Stimulating Factor Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial of Stem Cell Mobilization by Granulocyte-Colony-Stimulating Factor in Patients With Acute Myocardial Infarction. Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Reduction of infarct size (measured by Tc-sestamibi scintigraphy) [ Time Frame: measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months ]

Secondary Outcome Measures:

Left ventricular ejection fraction [ Time Frame: Left ventricular ejection fraction ]
Incidence of angiographic restenosis [ Time Frame: 6 months ]

Enrollment:	114
Study Start Date:	February 2004
Study Completion Date:	July 2005

Arms	Assigned Interventions
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 Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
2: Placebo Comparator Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.	Other: Placebo Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.

Detailed Description:

Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126100

Locations

Germany
Deutsches Herzzentrum
Munich, Germany, 80636
671. Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Wilhelm Sander Foundation

Schulz Foundation

Else Kröner Fresenius Foundation

Investigators

Study Chair:	Albert Schomig, MD	Deutsches Herzzentrum Muenchen
Principal Investigator:	Adnan Kastrati, MD	Deutsches Herzzentrum Muenchen

More Information

Publications:

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.

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. Epub 2001 Aug 14.

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.

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. Epub 2005 Feb 20.

ClinicalTrials.gov Identifier:	NCT00126100 History of Changes
Other Study ID Numbers:	GE IDE No. I01003, KKF 10-02, KKF 04-03
Study First Received:	August 1, 2005
Last Updated:	November 23, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:

Stem Cells

Additional relevant MeSH terms:

Heart Diseases
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia

Cardiovascular Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010