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Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

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.
 
ClinicalTrials.gov Identifier: NCT01130896
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

Condition or disease
Arrhythmias, Cardiac

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.

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Study Type : Observational
Actual Enrollment : 1509 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
Actual Study Start Date : May 2003
Actual Primary Completion Date : January 22, 2015
Actual Study Completion Date : January 22, 2015

Resource links provided by the National Library of Medicine


Group/Cohort
MRI and Cardiac Devices
Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD



Primary Outcome Measures :
  1. Device Malfunction [ Time Frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months) ]
    Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline

  2. 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)


Secondary Outcome Measures :
  1. Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance [ Time Frame: Immediately post MRI (up to 2 hours) ]
    We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130896


Locations
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United States, Maryland
Johns Hopkins Hospital, Blalcok 5 MRI
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Henry R. Halperin, M.D. Johns Hopkins University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01130896    
Other Study ID Numbers: RPN03-08-12-11
First Posted: May 26, 2010    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Johns Hopkins University:
MRI, pacemakers, Defibrillator
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes