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
  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 ]

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

  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

Contacts
Contact: Ali Yilmaz, MD +49-711-8101 ext 5587 ali.yilmaz@rbk.de

Locations
Germany
Robert-Bosch-Krankenhaus, Division of Cardiology Recruiting
Stuttgart, Germany, 70376
Contact: Ali Yilmaz, MD    +49-711-8101 ext 5587    ali.yilmaz@rbk.de   
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: Prof. Dr. med. U. Sechtem, Division of Cardiology, Robert-Bosch-Krankenhaus
ClinicalTrials.gov 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
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Ferumoxides
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014