Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00356239
First received: July 24, 2006
Last updated: April 9, 2007
Last verified: April 2007

July 24, 2006
April 9, 2007
July 2006
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00356239 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla
Evaluation of Safety and Feasibility Magnetic Resonance Imaging of the Heart at 1.5 Tesla In Patients With Implantable Cardioverter Defibrillators

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Not Provided
Not Provided
Not Provided
Not Provided
  • Defibrillators, Implantable
  • Heart Failure, Congestive
Not Provided
Not Provided
Naehle CP, Strach K, Thomas D, Meyer C, Linhart M, Bitaraf S, Litt H, Schwab JO, Schild H, Sommer T. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol. 2009 Aug 4;54(6):549-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
Not Provided
Not Provided

Inclusion Criteria:

  • Implantable Cardioverter Defibrillator
  • congestive heart failure
  • informed consent

Exclusion Criteria:

  • Non-MRI-compatible implants
Both
Not Provided
No
Contact: Torsten Sommer, MD +49-163-6113875 t.sommer@uni-bonn.de
Contact: Claas P Naehle, MD +49-178-4001619 cp@naehle.net
Germany
 
NCT00356239
201/05
Yes
Not Provided
University Hospital, Bonn
Not Provided
Principal Investigator: Nikos Werner, MD University of Bonn, Department of Cardiology
University Hospital, Bonn
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP