Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Robert Bosch Gesellschaft für Medizinische Forschung mbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:
NCT00886444
First received: April 20, 2009
Last updated: July 20, 2011
Last verified: April 2009

April 20, 2009
July 20, 2011
March 2009
August 2011   (final data collection date for primary outcome measure)
Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran) [ Time Frame: within 5 - 15 days after myocardial infarction ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886444 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction

The aim of this study is to:

  • clarify whether macrophage imaging using ferucarbotran is able to delineate the region of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;
  • identify possible differences in infarct imaging using ferucarbotran for macrophage imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and
  • evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with ferucarbotran in the setting of acute myocardial infarction.
Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Acute Myocardial Infarction
Drug: Ferucarbotran (Resovist)
single time intravenous bolus injection of a contrast agent
Other Name: Resovist
Experimental: Ferucarbotran
Intervention: Drug: Ferucarbotran (Resovist)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

  • contraindication to CMR or Magnevist® or Resovist®
Both
18 Years to 80 Years
No
Contact: Ali Yilmaz, MD +49-711-8101 ext 5587 ali.yilmaz@rbk.de
Germany
 
NCT00886444
NIMINI-1, RBK-143
No
Prof. Dr. med. U. Sechtem, Division of Cardiology, Robert-Bosch-Krankenhaus
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Not Provided
Study Director: Udo Sechtem, MD Robert Bosch Medical Center
Robert Bosch Gesellschaft für Medizinische Forschung mbH
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP