Imaging With a Radio Tracer to Guide VT Ablations
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|ClinicalTrials.gov Identifier: NCT01250912|
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia Arrhythmia||Drug: 123I-metaiodobenzylguanidine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Three Dimension Neuron Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Ventricular Tachycardia Ablations|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
U.S. FDA Resources
Experimental: Imaging Tracer
No arms, the Radio tracer will be used in all subjects imaging tests.
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.
Other Name: MIGB
- Imaging of Nerve distribution in heart [ Time Frame: 6 months after procedure ]Specific Aim 1: Evaluate if areas of left ventrical (LV) denervation measured by cardiac 123I-metaiodobenzylguanidine (MIBG) SPECT imaging (innervation map) can be integrated into the CartoXP electrophysiology mapping system. Participants will be followed for 6 months for an episode of Ventricular Tachycardia.
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): NCT01250912
|United States, Maryland|
|University of Maryland Medical Center, EP Lab, Rm. N3W77|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Timm R Dickfeld, MD,Ph.D||University of Maryland|