Imaging With a Radio Tracer to Guide VT Ablations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01250912
First received: July 28, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Ventricular Tachycardia
Arrhythmia
Drug: 123I-metaiodobenzylguanidine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: Imaging Tracer
No arms, the Radio tracer will be used in all subjects imaging tests.
Drug: 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.
Other Name: MIGB

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient under 18 years old
  • Inability to sign consent
  • Pregnant Women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250912

Contacts
Contact: Timm M Dickfeld, MD, Ph.D 410-328-6056 tdickfel@medicine.umaryland.edu
Contact: Stephen R Shorofsky, MD, Ph.D 410-328-6056 sshorof@medicine.umaryland.edu

Locations
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    tdickfel@medicine.umaryland.edu   
Contact: Stephen R Shorofsky, MD, Ph.D    410-328-6056    sshorofs@medicine.umaryland.edu   
Principal Investigator: Timm M Dickfeld, MD, Ph.D         
Sub-Investigator: Stephen R Shorofsky, MD, Ph.D         
Sub-Investigator: Anastasios P Saliaris, MD, Ph.D         
Sponsors and Collaborators
University of Maryland
GE Healthcare
Investigators
Principal Investigator: Timm R Dickfeld, MD,Ph.D University of Maryland
  More Information

Publications:
Responsible Party: Timm Dickfeld, MD, Ph.D, University of Maryland Medical Center
ClinicalTrials.gov Identifier: NCT01250912     History of Changes
Other Study ID Numbers: HP-00043324
Study First Received: July 28, 2010
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Ablation
Arrythmia
Imaging

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 18, 2014