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Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Johns Hopkins University.
Recruitment status was:  Recruiting
Information provided by:
Johns Hopkins University Identifier:
First received: May 20, 2010
Last updated: May 25, 2010
Last verified: May 2010

May 20, 2010
May 25, 2010
May 2003
October 2011   (Final data collection date for primary outcome measure)
Number of Patients with adverse events as a measure of Safety and Tolerability [ Time Frame: 1-2 hours and up to 5 years ]
Changes in device testing pre vs. post MRI and long-term follow-up (at 3 months and longest follow-up att he time of analysis; up to 5 years post MRI)Tests include pacing thresholds, sensing, battery life and lead impedences as well as patient reports of any discomfort related to MRI
Same as current
No Changes Posted
Imaging artifacts produced by the implanted device and device sensing of noise artifact produced by MRI [ Time Frame: 1 -2 days ]
We will evaluate whether or not the artifacts produced are significant enough to prevent dignostic interpretation of images
Same as current
Not Provided
Not Provided
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance Imaging Studies using an established safety protocol.
This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Implanted Cardiac Rhythm Management Devices
Arrhythmias, Cardiac
Not Provided
MRI and Cardiac Devices
Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's

Exclusion Criteria:

  • Pacemaker dependent patients with ICD's
  • Patients with other contraindication to MRI
Sexes Eligible for Study: All
9 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Henry R. Halperin, M.D., M.A., Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Henry R. Halperin, M.D. Johns Hopkins University
Johns Hopkins University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP