Back to results

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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

G-CSF Granulocyte-Colony Stimulating Factor

Placebo

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Stem Cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Deutsches Herzzentrum
671. Medizinische Klinik, Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Left ventricular ejection fraction

Incidence of angiographic restenosis

Full Information

NCT ID

NCT00126100

First Posted

August 1, 2005

Last Updated

November 23, 2007

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Wilhelm Sander Foundation, Schulz Foundation, Else Kröner Fresenius Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00126100

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Wilhelm Sander Foundation, Schulz Foundation, Else Kröner Fresenius Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Stem Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

G-CSF Granulocyte-Colony Stimulating Factor

Other Intervention Name(s)

Neupogen (Filograstim), Granocyte (Lenograstim)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Left ventricular ejection fraction

Time Frame

Left ventricular ejection fraction

Title

Incidence of angiographic restenosis

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Albert Schomig, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Adnan Kastrati, MD

Organizational Affiliation

Deutsches Herzzentrum Muenchen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deutsches Herzzentrum

City

Munich

ZIP/Postal Code

80636

Country

Germany

Facility Name

671. Medizinische Klinik, Klinikum rechts der Isar

City

Munich

ZIP/Postal Code

81675

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

11504914

Citation

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.

Results Reference

background

PubMed Identifier

11283669

Citation

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.

Results Reference

background

PubMed Identifier

15723072

Citation

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.

Results Reference

background

PubMed Identifier

16507801

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs