- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02071680
Autonomic Innervation and MIBG Imaging (MIBG-AF)
Cardiac Mapping of Autonomic Atrial Innervation and Its Relation to MIBG Nuclear Imaging in Patients With Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Iodine-123 Meta-iodobenzylguanidine
123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance
Time Frame: 2 years
|
The concordance of the 123I-mIBG visual images with the identification of autonomic sites as determined by high frequency stimulation (HFS).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observation of effects
Time Frame: 2 years
|
The effects of radiofrequency ablation of AF on cardiac innervation will be observed visually on 123l-mlBG images and clinically with participant follow up.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert Lemery, MD, Ottawa Heart Institute Research Corporation
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20140815-01H
Plan for Individual participant data (IPD)
Study Data/Documents
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Published article
Information comments: DOI: http://dx.doi.org/10.1016/j.hrthm.2016.08.038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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