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

November 23, 2007 updated by: Deutsches Herzzentrum Muenchen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Other Names:
  • Neupogen (Filograstim)
  • Granocyte (Lenograstim)
Placebo Comparator: 2
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction
Time Frame: Left ventricular ejection fraction
Left ventricular ejection fraction
Incidence of angiographic restenosis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Else Kröner Fresenius Foundation
Wilhelm Sander Foundation
Schulz Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

August 1, 2005

First Submitted That Met QC Criteria

August 1, 2005

First Posted (Estimate)

August 2, 2005

Study Record Updates

Last Update Posted (Estimate)

November 26, 2007

Last Update Submitted That Met QC Criteria

November 23, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. I01003
  • KKF 10-02
  • KKF 04-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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