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
| Tracking Information | |||||
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| First Received Date ICMJE | May 20, 2010 | ||||
| Last Updated Date | May 25, 2010 | ||||
| Start Date ICMJE | May 2003 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01130896 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices | ||||
| Official Title ICMJE | Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD) | ||||
| Brief Summary | Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance Imaging Studies using an established safety protocol. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with Implanted Cardiac Rhythm Management Devices |
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| Condition ICMJE | Arrhythmias, Cardiac | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | MRI and Cardiac Devices | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | October 2011 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 9 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01130896 | ||||
| Other Study ID Numbers ICMJE | 03-08-12-11 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Henry R. Halperin, M.D., M.A., Johns Hopkins University | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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