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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates. The purpose of this study is to image the nerves inside the heart of those patients. The investigators want to find out if abnormalities in the nervous system in the heart can help the physician to find the area that needs to be burnt away.
Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better.
The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia)
Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging Tracer | Experimental | No arms, the Radio tracer will be used in all subjects imaging tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 123I-metaiodobenzylguanidine | Drug | FDA Approved for use in Cancer patients. This use is Off Label. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Median Segmental MIBG Uptake at Baseline | The median uptake of the standard 17 heart segments was determined at baseline | Baseline |
| Median Segmental MIBG Uptake at 6 Months After Ablation | MIBG/SPECT imaging 6 months after ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timm R Dickfeld, MD,Ph.D | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center, EP Lab, Rm. N3W77 | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19467512 | Background | Tian J, Smith MF, Jeudy J, Dickfeld T. Multimodality fusion imaging using delayed-enhanced cardiac magnetic resonance imaging, computed tomography, positron emission tomography, and real-time intracardiac echocardiography to guide ventricular tachycardia ablation in implantable cardioverter-defibrillator patients. Heart Rhythm. 2009 Jun;6(6):825-8. doi: 10.1016/j.hrthm.2009.02.032. Epub 2009 Feb 24. No abstract available. | |
| 19207761 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving MIBG Imaging | All patients received MIBG imaging before and 6 months after VT ablation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MIBG Imaging on Top of Standard of Care VT Ablation | MIBG/SPECT imaging prior to, and 6 months after the ablation. 123I-metaiodobenzylguanidine: FDA Approved for use in Cancer patients. This use is Off Label. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline | Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage <0.5mV using Standard 17-segment American Heart Association areas. | Posted | Count of Participants | Participants | Baseline |
|
6 months
Clinicaltrials.gov definitions were used
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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 | MIBG Imaging on Top of Standard of Care VT Ablation | MIBG/SPECT imaging prior to, and 6 months after the ablation. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to unrelated non cardiac cause | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timm-Michael Dickfeld | University of Maryland, Baltimore | 410-328-7801 | tdickfel@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2009 | May 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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|
|
| 6 months after ablation |
| Background |
| Tian J, Smith MF, Chinnadurai P, Dilsizian V, Turgeman A, Abbo A, Gajera K, Xu C, Plotnick D, Peters R, Saba M, Shorofsky S, Dickfeld T. Clinical application of PET/CT fusion imaging for three-dimensional myocardial scar and left ventricular anatomy during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):567-604. doi: 10.1111/j.1540-8167.2008.01377.x. |
| 18417016 | Background | Dickfeld T, Kocher C. The role of integrated PET-CT scar maps for guiding ventricular tachycardia ablations. Curr Cardiol Rep. 2008 Mar;10(2):149-57. doi: 10.1007/s11886-008-0025-1. |
| 25713216 | Result | Klein T, Abdulghani M, Smith M, Huang R, Asoglu R, Remo BF, Turgeman A, Mesubi O, Sidhu S, Synowski S, Saliaris A, See V, Shorofsky S, Chen W, Dilsizian V, Dickfeld T. Three-dimensional 123I-meta-iodobenzylguanidine cardiac innervation maps to assess substrate and successful ablation sites for ventricular tachycardia: feasibility study for a novel paradigm of innervation imaging. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):583-91. doi: 10.1161/CIRCEP.114.002105. Epub 2015 Feb 23. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ejection Fraction | Mean | Standard Deviation | percent of LV ejection fraction |
|
| Comorbidities | Count of Participants | Participants |
|
| NYHA Heart Class | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Median Segmental MIBG Uptake at Baseline | The median uptake of the standard 17 heart segments was determined at baseline | Posted | Median | Inter-Quartile Range | percentage of maximum uptake | Baseline |
|
|
|
| Secondary | Median Segmental MIBG Uptake at 6 Months After Ablation | MIBG/SPECT imaging 6 months after ablation. 123I-metaiodobenzylguanidine: For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) was administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) was acquired beginning 15 minutes after tracer injection. | Posted | Mean | Inter-Quartile Range | percentage of maximum uptake | 6 months after ablation |
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| 1 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |