Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)
NCT ID: NCT00126100
Last Updated: 2007-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
114 participants
INTERVENTIONAL
2004-02-29
2005-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.
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
Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days.
Placebo
Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Placebo
Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Successful percutaneous coronary intervention \[PCI\] (performed within 12 hours from symptom onset)
* Scintigraphic infarct size \>5% of left ventricle
* Written informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wilhelm Sander Foundation
UNKNOWN
Schulz Foundation
UNKNOWN
Else Kröner Fresenius Foundation
OTHER
Deutsches Herzzentrum Muenchen
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Albert Schomig, MD
Role: STUDY_CHAIR
Deutsches Herzzentrum Muenchen
Adnan Kastrati, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum Muenchen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deutsches Herzzentrum
Munich, , Germany
671. Medizinische Klinik, Klinikum rechts der Isar
Munich, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KKF 10-02
Identifier Type: -
Identifier Source: secondary_id
KKF 04-03
Identifier Type: -
Identifier Source: secondary_id
GE IDE No. I01003
Identifier Type: -
Identifier Source: org_study_id