Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01130896
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 ] [ Designated as safety issue: Yes ]
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
Complete list of historical versions of study NCT01130896 on ClinicalTrials.gov Archive Site
Imaging artifacts produced by the implanted device and device sensing of noise artifact produced by MRI [ Time Frame: 1 -2 days ] [ Designated as safety issue: No ]
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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
Both
9 Years and older
No
Contact: Rozann D Hansford, MPH, RN 410-614-6013 RozHansford@hotmail.com
United States
 
NCT01130896
03-08-12-11
Yes
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