Imaging With a Radio Tracer to Guide VT Ablations

NCT01250912 | Completed Results DMC

• 1 other identifier: HP-00043324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventricular Tachycardia; Arrhythmia

Keywords

Ablation; Arrythmia; Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Median Segmental MIBG Uptake at Baseline

  Baseline

• Median Segmental MIBG Uptake at 6 Months After Ablation

  6 months after ablation

Study Arms (1)

Imaging Tracer

EXPERIMENTAL

No arms, the Radio tracer will be used in all subjects imaging tests.

Drug: 123I-metaiodobenzylguanidine

Interventions

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.

Also known as: MIGB

Imaging Tracer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ventricular arrhythmias requiring VT Ablation
• Patients must be 18 years of age or older
• Patient must be able to sign consent form
• Patient must be willing to come back for the 6 month visit for additional study procedures

You may not qualify if:

• Patient under 18 years old
• Inability to sign consent
• Pregnant Women

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Maryland Medical Center, EP Lab, Rm. N3W77

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• 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.

  PMID: 19467512 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.

  PMID: 19207761 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.

  PMID: 18417016 BACKGROUND

• 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.

  PMID: 25713216 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Timm-Michael Dickfeld
• Organization: University of Maryland, Baltimore

tdickfel@som.umaryland.edu

410-328-7801

Study Officials

• Timm R Dickfeld, MD,Ph.D

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: December 1, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 27, 2022
• Results First Posted: January 27, 2021

Record last verified: 2022-01

Locations

US (1)