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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
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance Imaging Studies using an established safety protocol.

Arrhythmias, Cardiac

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1000
Study Start Date: May 2003
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
MRI and Cardiac Devices

Detailed Description:
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.

Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Implanted Cardiac Rhythm Management Devices

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
  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 identifier: NCT01130896

Contact: Rozann D Hansford, MPH, RN 410-614-6013

United States, Maryland
Johns Hopkins Hospital, Blalcok 5 MRI Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Henry R Halperin, M.D., M.A.         
Sub-Investigator: Saman Nazarian, M.D.         
Sub-Investigator: Rozann Hansford, R.N., M.P.H.         
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Henry R. Halperin, M.D. Johns Hopkins University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Henry R. Halperin, M.D., M.A., Johns Hopkins University Identifier: NCT01130896     History of Changes
Other Study ID Numbers: 03-08-12-11
Study First Received: May 20, 2010
Last Updated: May 25, 2010

Keywords provided by Johns Hopkins University:
MRI, pacemakers, Defibrillator

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on March 22, 2017