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
Recruitment status was Recruiting
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01130896
First received: May 20, 2010
Last updated: May 25, 2010
Last verified: May 2010
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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
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 May 16, 2013