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Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI and Cardiac Devices | Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD |
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| Measure | Description | Time Frame |
|---|---|---|
| Device Malfunction | Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline | immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months) |
| Patient Safety | Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI) | assessed during MRI and immediate post MRI (up to 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance | We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images | Immediately post MRI (up to 2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Implanted Cardiac Rhythm Management Devices
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| Name | Affiliation | Role |
|---|---|---|
| Henry R. Halperin, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital, Blalcok 5 MRI | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29281579 | Result | Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267. | |
| 21969340 | Result |
| Label | URL |
|---|---|
| PubMed Citation #1 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI and Cardiac Devices | Clinically indicated MRI (all types) in patients with implanted pacemakers and implantable cardioverter-defibrillator (ICD) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI and Cardiac Devices | Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Device Malfunction | Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline | Posted | Count of Participants | Participants | immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI and Cardiac Devices | Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Power on reset | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry Halperin, MD | Johns Hopkins University | 410-955-2412 | nsaju1@jhmi.edu |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004. |
| 36716451 | Derived | Ra J, Oberdier MT, Suzuki M, Vaidya D, Liu Y, Hansford R, McVeigh D, Weltin V, Tao S, Thiemann DR, Nazarian S, Halperin HR. Implantable Defibrillator System Shock Function, Mortality, and Cause of Death After Magnetic Resonance Imaging. Ann Intern Med. 2023 Mar;176(3):289-297. doi: 10.7326/M22-2653. Epub 2023 Jan 31. |
| 32125255 | Derived | Rahsepar AA, Zimmerman SL, Hansford R, Guttman MA, Castro V, McVeigh D, Kirsch JE, Halperin HR, Nazarian S. The Relationship between MRI Radiofrequency Energy and Function of Nonconditional Implanted Cardiac Devices: A Prospective Evaluation. Radiology. 2020 May;295(2):307-313. doi: 10.1148/radiol.2020191132. Epub 2020 Mar 3. |
| PubMed Citation #2 | View source |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Patient Safety | Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI) | Posted | Count of Participants | Participants | assessed during MRI and immediate post MRI (up to 2 hours) |
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| Secondary | Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance | We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images | Posted | Count of Participants | Participants | Immediately post MRI (up to 2 hours) |
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| 0 |
| 1,509 |
| 0 |
| 1,509 |
| 8 |
| 1,509 |
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