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
Information provided by:
Robert Bosch Gesellschaft für Medizinische Forschung mbH Identifier:
First received: April 20, 2009
Last updated: July 20, 2011
Last verified: April 2009

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.

Condition Intervention Phase
Acute Myocardial Infarction
Drug: Ferucarbotran (Resovist)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferucarbotran Drug: Ferucarbotran (Resovist)
single time intravenous bolus injection of a contrast agent
Other Name: Resovist


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

Inclusion Criteria:

  • acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

  • contraindication to CMR or Magnevist® or Resovist®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00886444

Contact: Ali Yilmaz, MD +49-711-8101 ext 5587

Robert-Bosch-Krankenhaus, Division of Cardiology Recruiting
Stuttgart, Germany, 70376
Contact: Ali Yilmaz, MD    +49-711-8101 ext 5587   
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Study Director: Udo Sechtem, MD Robert Bosch Medical Center
  More Information

No publications provided

Responsible Party: Prof. Dr. med. U. Sechtem, Division of Cardiology, Robert-Bosch-Krankenhaus Identifier: NCT00886444     History of Changes
Other Study ID Numbers: NIMINI-1, RBK-143
Study First Received: April 20, 2009
Last Updated: July 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathologic Processes
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions processed this record on October 19, 2014