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

This study is currently recruiting participants.

Verified by Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK), April 2009

First Received: April 20, 2009 Last Updated: April 22, 2009 History of Changes

Sponsored by:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
Information provided by:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
ClinicalTrials.gov Identifier:	NCT00886444

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 II Phase III

MedlinePlus related topics: Heart Attack

Drug Information available for: Ferumoxides

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction

Further study details as provided by Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):

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:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ferucarbotran: Experimental	Drug: Ferucarbotran (Resovist) single time intravenous bolus injection of a contrast agent

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886444

Contacts

Contact: Ali Yilmaz, MD

+49-711-8101 ext 5587

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

Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)

Investigators

Study Director:

Udo Sechtem, MD

Robert-Bosch-Krankenhaus

More Information

No publications provided

Responsible Party:	Division of Cardiology, Robert-Bosch-Krankenhaus ( Prof. Dr. med. U. Sechtem )
Study ID Numbers:	NIMINI-1, RBK-143
Study First Received:	April 20, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00886444 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009