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Completed

NCT Number: NCT00631904

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Essentia Health

Duluth, Minnesota, 55805, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Cardiac troponin-I, creatine kinase, MB fraction, and myoglobin levels within the first 12 hours following the scans.

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Essentia Health

Other

Registry information

Official study title

SMDC Pacemaker-MRI Cohort Study

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2008
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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