Status:
COMPLETED
Safety of Magnetic Resonance Imaging in Patients With Pacemakers and Defibrillators
Lead Sponsor:
Johns Hopkins University
Conditions:
Conditions Requiring Diagnostic Evaluation
Eligibility:
All Genders
9-100 years
Brief Summary
Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to safety concerns. Recent work in our laboratory as well as our pilot study of approximately 500 patients has sho...
Detailed Description
The primary objective of this study is to develop a protocol, consistent with DHHS/ Center for Medicare and Medicaid Services (CMS) guidelines and requirements to further document safety in clinically...
Eligibility Criteria
Inclusion
- Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later) or ICD's (year 2000 or later)
- \-
Exclusion
- Inclusion: Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later) or ICD's (year 2000 or later)
- Exclusion:
- Patients with pacemaker models before 1996 and ICD models before year 2000.
- Pacemaker defendant patients with ICD.
- Patients who weighing less than 80 lbs.
- Patients less than 9 years old
- Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
- Pregnant patients will be excluded in their first trimester and will not get gadolinium at any time during their pregnancy
- Patient with abandoned/capped leads or leads implanted \<4 weeks unless the procedure is deemed critical by the referring physician and approved by the PI
Key Trial Info
Start Date :
December 30 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 22 2015
Estimated Enrollment :
1275 Patients enrolled
Trial Details
Trial ID
NCT02227004
Start Date
December 30 2011
End Date
January 22 2015
Last Update
April 20 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Hospital, Blalcok 5 MRI
Baltimore, Maryland, United States, 21205