Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

April 19, 2021 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital, Blalcok 5 MRI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Implanted Cardiac Rhythm Management Devices

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
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)
assessed during MRI and immediate post MRI (up to 2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately post MRI (up to 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Henry R. Halperin, M.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2003

Primary Completion (Actual)

January 22, 2015

Study Completion (Actual)

January 22, 2015

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPN03-08-12-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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