Autonomic Innervation and MIBG Imaging

NCT02071680 | Completed Phase 3

• 1 other identifier: 20140815-01H
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; atrial cardiac innervation; catheter ablation of atrial fibrillation; High Frequency Stimulation; ganglionated plexuses; 123I-mIBG; nuclear imaging

Outcome Measures

Primary Outcomes (1)

• Concordance

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

  2 years

Secondary Outcomes (1)

• Observation of effects

  2 years

Study Arms (1)

Iodine-123 Meta-iodobenzylguanidine

OTHER

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

Other: Iodine-123 Meta-iodobenzylguanidine

Interventions

Iodine-123 Meta-iodobenzylguanidine OTHER

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.

Also known as: 123I-mIBG

Iodine-123 Meta-iodobenzylguanidine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (2)

• 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.

  PMID: 16567283 BACKGROUND

• 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.

  PMID: 20188504 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Lemery, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: February 26, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

CA (1)