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

This study has been completed.
Information provided by (Responsible Party):
Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH Identifier:
First received: April 20, 2009
Last updated: November 6, 2014
Last verified: November 2014

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 ]

Enrollment: 20
Study Start Date: March 2009
Primary Completion Date: March 2010 (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®
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Please refer to this study by its identifier: NCT00886444

Robert-Bosch-Krankenhaus, Division of Cardiology
Stuttgart, Germany, 70376
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: Udo Sechtem, Prof. Dr. med. U. Sechtem, Division of Cardiology, Robert-Bosch-Krankenhaus, Robert Bosch Gesellschaft für Medizinische Forschung mbH Identifier: NCT00886444     History of Changes
Other Study ID Numbers: NIMINI-1, RBK-143
Study First Received: April 20, 2009
Last Updated: November 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions processed this record on November 24, 2015