Imaging With a Radio Tracer to Guide VT Ablations
Recruitment status was Recruiting
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Three Dimension Neuron Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Ventricular Tachycardia Ablations|
- Imaging of Nerve distribution in heart [ Time Frame: 6 months after procedure ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250912
|Contact: Timm M Dickfeld, MD, Ph.Dfirstname.lastname@example.org|
|Contact: Stephen R Shorofsky, MD, Ph.Demail@example.com|
|United States, Maryland|
|University of Maryland Medical Center, EP Lab, Rm. N3W77||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Timm M Dickfeld, MD, Ph.D 410-328-6056 firstname.lastname@example.org|
|Contact: Stephen R Shorofsky, MD, Ph.D 410-328-6056 email@example.com|
|Principal Investigator: Timm M Dickfeld, MD, Ph.D|
|Sub-Investigator: Stephen R Shorofsky, MD, Ph.D|
|Sub-Investigator: Anastasios P Saliaris, MD, Ph.D|
|Principal Investigator:||Timm R Dickfeld, MD,Ph.D||University of Maryland|