Safety of Cardiac Pacemakers in 1.5T Tesla MRI
|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: NCT00336011|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : June 12, 2006
|Condition or disease||Intervention/treatment|
|Heart Diseases||Device: Magnetic resonance imaging|
The presence of a cardiac pacemaker (PM) is currently considered an absolute contraindication to MR imaging, and most patients with PM are excluded from having MRI. In 2002 there were approximately 2.4 million patients in the US with cardiac PM, and this number is growing by 80,000 annually. A previous study has shown that MRI is indicated in 17% of all patients with pacemakers within 12 months of device placement 1, demonstrating the need for a practical and safe approach for performing MRI on PM patients.
The aim of this study is to develop a strategy for safe performance of MR imaging at 1.5T, which included exclusion of pacemaker dependent patients and those requiring imaging of the thorax, restriction of specific absorption rate (SAR) values to minimize the risk of lead heating, and PM reprogramming to avoid interference from time varying gradient fields. The safety of this approach is then evaluated in a large group of PM patients including assessment of potential myocardial thermal injury by measuring serum troponin I and pacing capture thresholds, and performing a 3-month follow-up to evaluate long-term effects.
|Study Type :||Observational|
|Enrollment :||75 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Studie Zur Sicherheit Von Medtronic Schrittmachern Bei Magnetresonanz-Bildgebungsverfahren an 1,5 Tesla-Systemen Study to Evaluate Safety Medtronic Pacemakers in MR Imaging at 1.5T Tesla)|
|Study Start Date :||December 2002|
|Study Completion Date :||January 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): NCT00336011
|University of Bonn, Department of Radiology|
|Bonn, NRW, Germany, 53127|
|Principal Investigator:||Torsten Sommer, MD||University of Bonn, Department of Radiology|