NCT00886444

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

April 20, 2009

Last Update Submit

November 6, 2014

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Ferucarbotran

EXPERIMENTAL
Drug: Ferucarbotran (Resovist)

Interventions

Ferucarbotran (Resovist)DRUG

single time intravenous bolus injection of a contrast agent

Also known as: Resovist
Ferucarbotran

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute myocardial infarction (STEMI or NSTEMI)

You may not qualify if:

  • contraindication to CMR or Magnevist® or Resovist®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert-Bosch-Krankenhaus, Division of Cardiology

Stuttgart, 70376, Germany

Location

MeSH Terms

Interventions

ferumoxides

Study Officials

  • Udo Sechtem, MD

    Robert Bosch Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. U. Sechtem, Division of Cardiology, Robert-Bosch-Krankenhaus

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 23, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations

DE(1)