Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices (BIDMC-MRI)
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|ClinicalTrials.gov Identifier: NCT03016429|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : February 27, 2018
|Condition or disease|
MRI is the preferred imaging modality for both acute and elective evaluation of many conditions. For example, for many diseases of the central nervous system, no other imaging modality provides the requisite soft tissue resolution to support critical care elements such as neurosurgical planning or assessment of intracranial malignancies.
Historically, MRIs were considered contraindicated for patients with CIEDs including PMs and ICDs. However, studies have demonstrated very high utilization of MRIs among patients eligible for CIEDs. In many cases, alternative imaging is either insufficient or, as with CT-myelography, poses substantial risks or procedural hurdles that may be less favorable than the potential risks of an MRI.
In recent years, a growing literature has suggested that MRIs can be performed safely in the setting of CIEDs if certain precautions are taken. Additionally, guidance documents have been released by professional societies including the American Heart Association (AHA) and the American College of Radiology (ACR) outlining recommended safety measures that can be taken to minimize risk and maximize benefit for patients in need of imaging. However, there are fewer data on performing MRIs in pacemaker-dependent patients with ICDs, who were excluded from the largest published study as well as the MagnaSafe Registry. Thus, demonstrating the safety and clinical utility of performing MRIs in this context is of high importance.
In response to urgent clinical considerations, Beth Israel Deaconess Medical Center has established a clinical protocol to provide safe MRIs in cases of compelling clinical indications, with close supervision and oversight from Radiology and Cardiac Electrophysiology staff. Thus, the investigators now propose a prospective study to evaluate safety and clinical outcomes for patients treated under this clinical protocol.
Specifically, this study proposes to perform a prospective clinical trial in patients with CIEDs that have a clinical need for MRI as outpatients to determine:
- Safety according to the incidence rates of acute major and minor adverse events according to pre-specified definitions.
- Clinical outcomes and scan utility affecting patients' survival and quality of life and treatment, including acute and longitudinal changes in device parameters, the need for system revision, and proportion of MRI findings influencing clinical management including medical or surgical interventions, and diagnostic or prognostic changes.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
- Number of Patients with Any of the Following Major Adverse Events [ Time Frame: Change from baseline at 1 week and 6 months ]
- Acute loss of pacing peri-MRI (defined in scanner, or after scan prior to discharge)
- Inappropriate shock or ATP therapy peri-MRI
- Any death peri-MRI adjudicated to be related to the scan
- Number of Patients with Any of the Following Minor Adverse Events [ Time Frame: Change from baseline at 1 week and 6 months ]
- Clinically significant (symptoms or hemodynamic compromise) inappropriate pacing (e.g. undersensing or inappropriate asynchronous pacing)
- Any clinically significant arrhythmias peri-MRI
- Power-on-reset events
- Acute variation in pre/post MRI capture thresholds ≥ 50%
- Acute variation in pre/post MRI lead impedance ≥ 30%
- Acute variation in pre/post MRI P/R wave amplitude ≥ 50%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016429
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Daniel Kramer, MD||Beth Israel Deaconess Medical Center|