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Trial record 25 of 245 for:    "ottawa heart institute"

Autonomic Innervation and MIBG Imaging (MIBG-AF)

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ClinicalTrials.gov Identifier: NCT02071680
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Robert Lemery, Ottawa Heart Institute Research Corporation

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Iodine-123 Meta-iodobenzylguanidine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Mapping of Autonomic Atrial Innervation and Its Relation to MIBG Nuclear Imaging in Patients With Atrial Fibrillation
Study Start Date : March 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Arm Intervention/treatment
Iodine-123 Meta-iodobenzylguanidine
123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation
Other: Iodine-123 Meta-iodobenzylguanidine

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 Name: 123I-mIBG




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071680


Locations
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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Robert Lemery, MD Ottawa Heart Institute Research Corporation

Study Data/Documents: Published article  This link exits the ClinicalTrials.gov site
DOI: http://dx.doi.org/10.1016/j.hrthm.2016.08.038

Publications:
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Responsible Party: Robert Lemery, Principal Investigator, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02071680     History of Changes
Other Study ID Numbers: 20140815-01H
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Keywords provided by Robert Lemery, Ottawa Heart Institute Research Corporation:
atrial fibrillation
atrial cardiac innervation
catheter ablation of atrial fibrillation
High Frequency Stimulation
ganglionated plexuses
123I-mIBG
nuclear imaging

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Iodine
3-Iodobenzylguanidine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals