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. Identifier: NCT00631904
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : September 2, 2011
Information provided by:
Essentia Health

Brief Summary:

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
Cardiovascular Disease

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SMDC Pacemaker-MRI Cohort Study
Study Start Date : January 2005
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Single Observation
Patients with permanent pacemakers undergoing medically indicated MRI scanning.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Cardiac troponin-I, creatine kinase, MB fraction, and myoglobin levels within the first 12 hours following the scans. [ Time Frame: 12 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Permanent pacemaker or implantable cardioverter-defibrillator (ICD) implanted for at least 6 weeks.

Inclusion Criteria:

  • Permanent pacemaker or ICD implanted for at least 6 weeks
  • Referred for medically indicated MRI
  • Age greater or equal to 18 years old

Exclusion Criteria:

  • ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm-2 MDT GEM-I series
  • Epicardial coronary sinus lead or subcutaneous array
  • Unable to program all leads to bipolar configuration
  • Pacemaker Dependent
  • Device has reached elective replacement or end of life
  • Other usual contraindications to MRI scanning
  • The use of inotropic pharmacological agents, such as dobutamine, during the MRI

Information from the National Library of Medicine

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 identifier (NCT number): NCT00631904

United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Principal Investigator: Michael Mollerus, MD Essentia Health


Responsible Party: Michael Mollerus, MD, Essentia Health Identifier: NCT00631904     History of Changes
Other Study ID Numbers: 010503
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: September 2, 2011
Last Verified: August 2011

Keywords provided by Essentia Health:

Additional relevant MeSH terms:
Cardiovascular Diseases