St. Mary's Duluth Clinic (SMDC) Pacemaker Magnetic Resonance Imaging (MRI) Study

This study has been completed.
Sponsor:
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00631904
First received: February 29, 2008
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SMDC Pacemaker-MRI Cohort Study

Resource links provided by NLM:


Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: January 2005
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single Observation
Patients with permanent pacemakers undergoing medically indicated MRI scanning.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Permanent pacemaker or implantable cardioverter-defibrillator (ICD) implanted for at least 6 weeks.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631904

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

Publications:

Responsible Party: Michael Mollerus, MD, Essentia Health
ClinicalTrials.gov Identifier: NCT00631904     History of Changes
Other Study ID Numbers: 010503
Study First Received: February 29, 2008
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Essentia Health:
Pacemaker

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014