St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study
|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: NCT00631904|
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : September 2, 2011
The purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required Magnetic Resonance Imaging (MRI) scans.
Patients with pacemakers are currently excluded from obtaining MRI scans. MRI scanning is now the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions.
Data suggests that patients with pacemakers, when properly monitored, can safely undergo MRI scanning, though the largest published study to date consists of 54 patients, and no long term follow-up has been published.
Though MRI cardiac scanning has been demonstrated to produce local tissue heating at the pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear.
This study will evaluate patients with permanent pacemakers undergoing medically indicated MRI scanning.
Patients will be followed for one year at 3, 6, and 12 months. Data collected will evaluate change in pacing thresholds over time as well as cardiac troponin I, creatinine kinase MB function, and myoglobin levels within the first 12 hours following the scans, side effects, symptoms, the need to make pacemaker program changes, and possible artifacts created by the pacemaker on the MRI scan.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||SMDC Pacemaker-MRI Cohort Study|
|Study Start Date :||January 2005|
|Primary Completion Date :||March 2011|
|Study Completion Date :||July 2011|
Patients with permanent pacemakers undergoing medically indicated MRI scanning.
- Any change greater than 1 volt at a pulse width of 0.5 ms in a pacemaker lead 12 months from an MRI scan [ Time Frame: 12 months ]
- Cardiac troponin-I, creatine kinase, MB fraction, and myoglobin levels within the first 12 hours following the scans. [ Time Frame: 12 hours ]
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): NCT00631904
|United States, Minnesota|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Michael Mollerus, MD||Essentia Health|