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. Identifier: NCT01130896
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : March 24, 2017
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.

Study Type : Observational
Actual Enrollment : 1000 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
Primary Completion Date : January 2017
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

  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. 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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT01130896

United States, Maryland
Johns Hopkins Hospital, Blalcok 5 MRI
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Henry R. Halperin, M.D. Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Johns Hopkins University Identifier: NCT01130896     History of Changes
Other Study ID Numbers: RPN03-08-12-11
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes