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

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ClinicalTrials.gov Identifier: NCT00886444
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Ferucarbotran (Resovist) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxides
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ferucarbotran Drug: Ferucarbotran (Resovist)
single time intravenous bolus injection of a contrast agent
Other Name: Resovist



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

  • contraindication to CMR or Magnevist® or Resovist®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886444


Locations
Germany
Robert-Bosch-Krankenhaus, Division of Cardiology
Stuttgart, Germany, 70376
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Investigators
Study Director: Udo Sechtem, MD Robert Bosch Medical Center

Responsible Party: Udo Sechtem, Prof. Dr. med. U. Sechtem, Division of Cardiology, Robert-Bosch-Krankenhaus, Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier: NCT00886444     History of Changes
Other Study ID Numbers: NIMINI-1
RBK-143
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases