St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||SMDC Pacemaker-MRI Cohort Study|
- 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 ] [ Designated as safety issue: Yes ]
- Cardiac troponin-I, creatine kinase, MB fraction, and myoglobin levels within the first 12 hours following the scans. [ Time Frame: 12 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||July 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Patients with permanent pacemakers undergoing medically indicated MRI scanning.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631904
|United States, Minnesota|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Michael Mollerus, MD||Essentia Health|