PVC-MIBG: Use of MIBG Scan Images in PVC Ablations

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT02279030
Collaborator
GE Healthcare (Industry)
20
1
55
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Study Details

Study Description

Brief Summary

The purpose of this study is to assess if Single Photon Emission Computed Tomography (SPECT) demonstrating cardiac innervation can be integrated into current electrophysiology voltage mapping system and provide improved guidance for ablation of PVCs.

Condition or Disease Intervention/Treatment Phase
  • Other: MIBG nuclear scan

Detailed Description

Premature ventricular contractions (PVC) are the most common arrhythmia to be observed in the absence of structural heart disease, and 'frequent' PVCs are estimated to occur in 1-4% of the general population.1 Idiopathic PVCs are usually associated with a benign course from the standpoint of arrhythmic death, but often result in significant symptoms for the patient such as palpitations, dizziness, pre-syncope and rarely syncope. More recently, a new concept of PVC- mediated cardiomyopathy has emerged that is reversible with suppression of the PVCs.2 Both of those patient populations are currently targeted with PVC suppressive therapy which often involves as the first step using medical therapy such as a beta blocker, calcium channel blocker or an antiarrhythmic. If those fail or if the patients wants to avoid medical therapy an ablation to eliminate the abnormal myocardial tissue that is the origin of the PVCs is often performed.

Radiofrequency ablation (RFA) for PVCs has been performed for several decades and has a well-defined safety and effectiveness profile in patients with symptomatic frequent ventricular ectopic beats and PVC-induced cardiomyopathy. Successful PVC suppression ≥80% of RV and LV PVCs has been reported to be as high as ~80% using an ablation approach.9 Studies found improvements in patient symptoms with elimination of PVCs. In LV dysfunction following ablation demonstrated a significant inverse correlation between EF and PVC burden before ablation, and a significant post procedural improvement in ejection fraction (EF) in 82% of patients who had abnormal systolic function before ablation.8 Improvement of the overall LV EF ranged from 13%-23% after PVC ablation.5,8,10

Autonomic innervation of the heart plays a major role in the normal regulation of myocardial function, heart rate, and coronary blood flow. Abnormal sympathetic cardiac innervation has been shown to have prognostic value for different heart diseases, e.g. heart transplant, coronary artery disease, heart failure, arrhythmias, etc. Importantly, there is a clear association with an increased cardiac morbidity and mortality in heart diseases. Patients with myocardial infarction as well as patients with heart failure exhibit well recognized abnormalities in autonomic tone. PVCs especially in the setting of preserved EF (normal heart patients) have frequently an automatic/triggered mechanism, which is influenced by the cardiac innervation.

Decreased reuptake by impaired myocardial presynaptic nerve terminals results in a buildup of these catecholamines in the synaptic cleft. This leads to a downregulation of postsynaptic beta-adrenergic receptors, with resultant worsening cardiomyopathy and increased arrhythmogenesis.

Cardiac sympathetic innervation can be directly imaged with commonly used nuclear radioisotope, 123I-meta-iodobenzylguanidine (123I-mIBG). As a norepinephrine analogue, 123I-mIBG is similarly released into the synaptic cleft in response to sympathetic input by presynaptic nerve terminals 123I-metaiodobenzylguanidine (123I-MIBG) allows visualization of the cardiac innervation, which could provide additional information to understand the origin, prognosis and pathophysiology of PVCs and guide potential ablation procedures.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Three Dimensional Neuro-cardiac Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Premature Ventricular Contractions Ablations
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Outcome Measures

Primary Outcome Measures

  1. Utilization of MIBG imaging for PVC ablations [2 years]

    To determine if MIBG imaging provides decreased PVC ablation time

  2. Decrease PVC occurrence [2 years]

    Does MIBG imaging allow for treatment that provides improved outcomes in decreasing PVCs

  3. Increase in Motility [2 years]

    Do MIBG follow-ups demonstrate an improvement in cardiac motility

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Scheduled for PVC ablation
Exclusion Criteria:
  • pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Medical Center Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore
  • GE Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Timm-Michael Dickfeld, CARDIAC ELECTROPHYSIOLOGY PHYSICIAN, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT02279030
Other Study ID Numbers:
  • HP-00062156
First Posted:
Oct 30, 2014
Last Update Posted:
Feb 8, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Timm-Michael Dickfeld, CARDIAC ELECTROPHYSIOLOGY PHYSICIAN, University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2022