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The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)
At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatients | MRI; Critical Care Monitoring, Device Programming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initiate ACLS protocol if lethal arrythmia develops | Other | Cardiac Rhythm Management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Device Function | Change in lead impedance or sensing | 3 years |
| Change in Thresholds of Pacing Lead | Measured in mA | 3 years |
| Dysrhythmias Noted During Scan | Change in heart rhythm | 3 years |
| Oxygen Saturation | Percentage of change or no change | 3 years |
| Change in heart rate | Measured as beats per minute on single-lead heart monitor. | 3 years |
| Patient Comments | Real-time patient report via intercom during scan of chest symptoms such as burning or aching | 3 years |
| Interference Between the Implanted Cardiac Electronic Device and MRI | Measure any change in device battery voltage | 3 years |
| Change in blood pressure | Monitored with automatic blood pressure cuff | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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For all patients in whom a clinical MRI examination is felt to be important in the patients care, and in whom the potential benefits clearly outweigh the risks of an MRI exam as referred from various primary and/or subspecialty physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Sanjaya K Gupta, MD | St. Luke's Hospital, Kansas City, Missouri | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33778621 | Derived | Gupta SK, Ya'qoub L, Wimmer AP, Fisher S, Saeed IM. Safety and Clinical Impact of MRI in Patients with Non-MRI-conditional Cardiac Devices. Radiol Cardiothorac Imaging. 2020 Oct 22;2(5):e200086. doi: 10.1148/ryct.2020200086. eCollection 2020 Oct. |
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There is no plan to share the IPD
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