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

August 31, 2011 updated by: Essentia Health

SMDC Pacemaker-MRI Cohort 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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essentia Health

Investigators

  • Principal Investigator: Michael Mollerus, MD, Essentia Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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