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

Acute Myocardial Infarction Clinical Trial

Official title:

Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886444
• Other study ID #: NIMINI-1
• Secondary ID: RBK-143
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 20, 2009
• Last updated: November 6, 2014
• Start date: March 2009

Study information

• Verified date: November 2014
• Source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

• contraindication to CMR or Magnevist® or Resovist®

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Ferucarbotran (Resovist)
single time intravenous bolus injection of a contrast agent

Locations

Country	Name	City	State
Germany	Robert-Bosch-Krankenhaus, Division of Cardiology	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran)		within 5 - 15 days after myocardial infarction	No