Back to resultsComparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ferucarbotran (Resovist)
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- acute myocardial infarction (STEMI or NSTEMI)
Exclusion Criteria:
- contraindication to CMR or Magnevist® or Resovist®
Sites / Locations
- Robert-Bosch-Krankenhaus, Division of Cardiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ferucarbotran
Arm Description
Outcomes
Primary Outcome Measures
Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran)
Secondary Outcome Measures
Full Information
NCT ID
NCT00886444
First Posted
April 20, 2009
Last Updated
November 6, 2014
Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH
1. Study Identification
Unique Protocol Identification Number
NCT00886444
Brief Title
Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
Official Title
Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Robert Bosch Gesellschaft für Medizinische Forschung mbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferucarbotran
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ferucarbotran (Resovist)
Other Intervention Name(s)
Resovist
Intervention Description
single time intravenous bolus injection of a contrast agent
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute myocardial infarction (STEMI or NSTEMI)
Exclusion Criteria:
contraindication to CMR or Magnevist® or Resovist®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udo Sechtem, MD
Organizational Affiliation
Robert Bosch Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Robert-Bosch-Krankenhaus, Division of Cardiology
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
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