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Autonomic Innervation and MIBG Imaging (MIBG-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Iodine-123 Meta-iodobenzylguanidine
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring atrial fibrillation, atrial cardiac innervation, catheter ablation of atrial fibrillation, High Frequency Stimulation, ganglionated plexuses, 123I-mIBG, nuclear imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years.
  • Symptoms including one or more of the following: palpitations, shortness of breath, dizziness, presyncope or syncope, chest pain, tiredness or lack of energy.
  • Failure of beta-blockers or at least one antiarrhythmic agent other than Amiodarone to prevent AF. In those patients who are not eligible to antiarrhythmic agents other than Amiodarone, patients may choose to undergo catheter ablation rather than starting Amiodarone.
  • Paroxysmal (self-terminating AF within 7 days) or persistent AF (requiring an intervention to terminate or lasting more than 7 days).

Exclusion Criteria:

  • Intracardiac thrombus as determined by transesophageal echocardiography
  • Class III or IV congestive heart failure
  • Persistent AF duration of more than 3 years
  • Myocardial infarction within the last 6 months
  • Left atrial size of greater than 55 mm determined by 2D echocardiogram
  • Inability to undergo a transesophageal echocardiogram or cardiac CT
  • Inability to undergo D-SPECT™ imaging
  • Inability to take Warfarin or the new oral anticoagulants
  • Previously received 123I-mIBG or 131I-mIBG
  • History or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated imaging agents
  • Use of medications for non-cardiac medical conditions that are known to interfere with 123I-mIBG uptake and these medications cannot be safely withheld for at least 24 hours before study procedures
  • Diagnosis of or signs or symptoms of a neurologic disease such as Parkinson's disease, multiple systems atrophy or Parkinsonian syndromes, or other diseases known to affect the sympathetic nervous system
  • Pregnancy as determined by a pre-procedure pregnancy tests

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Iodine-123 Meta-iodobenzylguanidine

Arm Description

123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation

Outcomes

Primary Outcome Measures

Concordance
The concordance of the 123I-mIBG visual images with the identification of autonomic sites as determined by high frequency stimulation (HFS).

Secondary Outcome Measures

Observation of effects
The effects of radiofrequency ablation of AF on cardiac innervation will be observed visually on 123l-mlBG images and clinically with participant follow up.

Full Information

First Posted
January 15, 2014
Last Updated
December 20, 2016
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02071680
Brief Title
Autonomic Innervation and MIBG Imaging
Acronym
MIBG-AF
Official Title
Cardiac Mapping of Autonomic Atrial Innervation and Its Relation to MIBG Nuclear Imaging in Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with symptomatic atrial fibrillation (AF), a rapid beating of the upper heart chambers, can undergo catheter ablation to control or eliminate their rhythm disorder. The radiopharmceutical 123I-mIBG (Adreview™ GE Healthcare) has been introduced to visually identify cardiac innervation. This study will use non-invasive evaluation using MIBG imaging to study if we can predict baseline autonomic characteristics in patients with AF, as well as clinical outcome based on post ablation imaging
Detailed Description
This is a single centre, interventional, Phase III trial using the radiopharmaceutical 123I-mIBG for imaging. In this pilot study, up to 7 eligible participants will undergo pre-ablation and post ablation nuclear imaging. The major objective of our study is to evaluate the relationship between non-invasive imaging of cardiac innervation with invasive mapping of atrial innervation as determined by High Frequency Stimulation (standard of care to physiologically document autonomic function). This will be followed by the clinical ablation procedure, as discussed by the cardiac electrophysiologist, consisting of pulmonary vein (PV) antral isolation, inclusive of regions of autonomic innervation, and sites showing complex fractionated atrial electrograms (CFAE) when clinically indicated. The secondary objective is to determine the relationship between catheter ablation of AF and non-invasive nuclear imaging of cardiac innervation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, atrial cardiac innervation, catheter ablation of atrial fibrillation, High Frequency Stimulation, ganglionated plexuses, 123I-mIBG, nuclear imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iodine-123 Meta-iodobenzylguanidine
Arm Type
Other
Arm Description
123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation
Intervention Type
Other
Intervention Name(s)
Iodine-123 Meta-iodobenzylguanidine
Other Intervention Name(s)
123I-mIBG
Intervention Description
A single injection of the 123I-mIBG will be given. Imaging will be done twice following injection: at 0120 minutes and 3-5 hours. The timing is dependent on the specific participant and imaging characteristics. The imaging is done for approximately 24 minutes at each time point.
Primary Outcome Measure Information:
Title
Concordance
Description
The concordance of the 123I-mIBG visual images with the identification of autonomic sites as determined by high frequency stimulation (HFS).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Observation of effects
Description
The effects of radiofrequency ablation of AF on cardiac innervation will be observed visually on 123l-mlBG images and clinically with participant follow up.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years. Symptoms including one or more of the following: palpitations, shortness of breath, dizziness, presyncope or syncope, chest pain, tiredness or lack of energy. Failure of beta-blockers or at least one antiarrhythmic agent other than Amiodarone to prevent AF. In those patients who are not eligible to antiarrhythmic agents other than Amiodarone, patients may choose to undergo catheter ablation rather than starting Amiodarone. Paroxysmal (self-terminating AF within 7 days) or persistent AF (requiring an intervention to terminate or lasting more than 7 days). Exclusion Criteria: Intracardiac thrombus as determined by transesophageal echocardiography Class III or IV congestive heart failure Persistent AF duration of more than 3 years Myocardial infarction within the last 6 months Left atrial size of greater than 55 mm determined by 2D echocardiogram Inability to undergo a transesophageal echocardiogram or cardiac CT Inability to undergo D-SPECT™ imaging Inability to take Warfarin or the new oral anticoagulants Previously received 123I-mIBG or 131I-mIBG History or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated imaging agents Use of medications for non-cardiac medical conditions that are known to interfere with 123I-mIBG uptake and these medications cannot be safely withheld for at least 24 hours before study procedures Diagnosis of or signs or symptoms of a neurologic disease such as Parkinson's disease, multiple systems atrophy or Parkinsonian syndromes, or other diseases known to affect the sympathetic nervous system Pregnancy as determined by a pre-procedure pregnancy tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lemery, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16567283
Citation
Lemery R, Birnie D, Tang AS, Green M, Gollob M. Feasibility study of endocardial mapping of ganglionated plexuses during catheter ablation of atrial fibrillation. Heart Rhythm. 2006 Apr;3(4):387-96. doi: 10.1016/j.hrthm.2006.01.009. Epub 2006 Feb 28.
Results Reference
background
PubMed Identifier
20188504
Citation
Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.
Results Reference
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Autonomic Innervation and MIBG Imaging

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