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Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130896
First Posted: May 26, 2010
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
May 20, 2010
May 26, 2010
March 24, 2017
May 2003
January 2017   (Final data collection date for primary outcome measure)
  • Device Malfunction [ Time Frame: assessed immediate post MRI (1-2 hours post baseline) and 1-6 weeks post MRI ]
    Number of patients with change in device testing (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds not to exceed 30 percent from baseline
  • Patient Safety [ Time Frame: assessed during MRI and immediate post MRI (up to 2 hours) ]
    Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)
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
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 ]
We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images
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
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 (MR) 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
Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
January 2017
January 2017   (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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01130896
RPN03-08-12-11
Yes
Not Provided
Plan to Share IPD: Yes
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Henry R. Halperin, M.D. Johns Hopkins University
Johns Hopkins University
March 2017