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

November 6, 2014 updated by: Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus, Division of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

  • contraindication to CMR or Magnevist® or Resovist®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ferucarbotran
Drug: Ferucarbotran (Resovist)
single time intravenous bolus injection of a contrast agent
Other Names:
  • Resovist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 5 - 15 days after myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (ESTIMATE)

April 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMINI-1
  • RBK-143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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