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Completed

NCT Number: NCT01130896

Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

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

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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

9 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital, Blalcok 5 MRI

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Important dates

Study start
2003
Primary completion
2015
Study completion
2015
First posted
May 26, 2010
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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