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Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01130896
First received: May 20, 2010
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

Condition
Arrhythmias, Cardiac

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 1000
Actual Study Start Date: May 2003
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
MRI and Cardiac Devices
Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD

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.
  Eligibility

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130896

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01130896     History of Changes
Other Study ID Numbers: RPN03-08-12-11
Study First Received: May 20, 2010
Last Updated: March 22, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 23, 2017