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NCT02227004 · ClinicalTrials.gov registry record
Safety of Magnetic Resonance Imaging in Patients With Pacemakers and Defibrillators
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 1,275
- Enrollment target
NCT02227004: Completed study, sponsored by Johns Hopkins University.
NCT02227004 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 1,275 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02227004 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 1,275 participants
- Enrollment target
Study 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 shown the safety of most contemporary implanted rhythm management devices in the MRI environment given appropriate precautions. Because the investigators have completed testing in animals weighing as little as 80 lbs. without incident, the investigators feel they can safely image children at this weight or greater (Circulation 2004; 110:475-482). The goal of this study is to expand on our pilot study and to develop a protocol, consistent with the Department of Health and Human Services (DHHS) requirements, that will increase our safety experience with clinically indicated MR imaging in patients with implanted cardiac pacemakers and ICD's. This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the setting of implantable devices will be discussed and informed consent obtained. The type of device and leads will be ascertained. Patients will be monitored by a physician or a Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming during the study. When imaging children who meet age and weight criteria, a physician will be present during the entire study. Fellow and attending radiology and electrophysiology support will be available in house in all cases. Standard device testing including battery voltages, thresholds, sensing and lead impedances will be measured.
Primary Outcome
Device function will be assessed by comparing pre-vs. post MRI battery voltage, impedance, sensing and capture thresholds
Interventions
- DIAGNOSTIC_TEST Perform MRI in patients with pacemaker or ICD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,275 participants |
| Start Date | 2011-12-30 |
| Est. Completion | 2015-01-22 |
What the finished NCT02227004 record still lists
NCT02227004 is an observational study that tracks outcomes without assigning an intervention. Its 1,275 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Perform MRI in patients with pacemaker or ICD is the first listed.
NCT02227004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02227004 about?
NCT02227004 is a clinical study titled "Safety of Magnetic Resonance Imaging in Patients With Pacemakers and Defibrillators". 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 shown the safety of most contemporary implanted rhythm management devices in the MRI environment given ...
What is the current status of trial NCT02227004?
This trial is currently completed. The enrollment target is 1,275 participants. The study started on 2011-12-30. Estimated completion is 2015-01-22.
What interventions are being tested in trial NCT02227004?
The interventions under investigation include: Perform MRI in patients with pacemaker or ICD (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02227004?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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