Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01130896
First received: May 20, 2010
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance 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:
  • Number of Patients with adverse events as a measure of Safety and Tolerability [ Time Frame: 1-2 hours and up to 5 years ] [ Designated as safety issue: Yes ]
    Changes in device testing pre vs. post MRI and long-term follow-up (at 3 months and longest follow-up att he time of analysis; up to 5 years post MRI)Tests include pacing thresholds, sensing, battery life and lead impedences 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 ] [ Designated as safety issue: No ]
    We will evaluate whether or not the artifacts produced are significant enough to prevent dignostic interpretation of images


Estimated Enrollment: 1000
Study Start Date: May 2003
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
MRI and Cardiac Devices

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
Genders Eligible for Study:   Both
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

Contacts
Contact: Rozann D Hansford, MPH, RN 410-614-6013 RozHansford@hotmail.com

Locations
United States, Maryland
Johns Hopkins Hospital, Blalcok 5 MRI Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Henry R Halperin, M.D., M.A.         
Sub-Investigator: Saman Nazarian, M.D.         
Sub-Investigator: Rozann Hansford, R.N., M.P.H.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Henry R. Halperin, M.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Henry R. Halperin, M.D., M.A., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01130896     History of Changes
Other Study ID Numbers: 03-08-12-11
Study First Received: May 20, 2010
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

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 October 16, 2014