Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00356239|
Recruitment Status : Unknown
Verified April 2007 by University Hospital, Bonn.
Recruitment status was: Recruiting
First Posted : July 25, 2006
Last Update Posted : April 11, 2007
|Condition or disease|
|Defibrillators, Implantable Heart Failure, Congestive|
The presence of an implantable cardioverter defibrillators (ICD) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. As a result from studies such as MADIT I, MADIT II, SCDHeft etc. the number of patients with ICDs has been continuously growing over the past years, ans this development will continue.
The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and ICD reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of ICD patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a follow-up 6 weeks after MR imaging to evaluate long-term effects.
|Study Type :||Observational|
|Enrollment :||25 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators|
|Study Start Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356239
|Contact: Torsten Sommer, MDemail@example.com|
|Contact: Claas P Naehle, MDfirstname.lastname@example.org|
|University of Bonn, Department of Cardiology||Recruiting|
|Bonn, NRW, Germany, 53127|
|Contact: Torsten Sommer, MD +49-163-7113875 email@example.com|
|Contact: Claas P Naehle, MD +49-178-4001619 firstname.lastname@example.org|
|Principal Investigator:||Nikos Werner, MD||University of Bonn, Department of Cardiology|