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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:
NCT00886444
First received: April 20, 2009
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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

  Eligibility

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

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 ClinicalTrials.gov identifier: 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
  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
ClinicalTrials.gov 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:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Ferumoxides
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014