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Atrial FibrillationfMRINCT02524028

Relationship Between Autonomic Central Nervous System Activation and Atrial Fibrillation Using Functional MRI (fMRI)

An observational study of Atrial Fibrillation, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The fMRI study is a prospective study with the objective of evaluating the effects of the autonomic central nervous system on the regulation of heart rate in patients with atrial fibrillation (AF). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation
How many people
21 participants
Where
1 siteUnited States
Study dates
Jun 2012to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Potential participants for the fMRI Study will be recruited from the Cardiology/Electrophysiology (EP) clinic during normally scheduled clinic visits. Control participants will be recruited from other hospital clinics.

Who may be able to join

  • AF patients presenting for DCCV
  • Right-handed

Who cannot join

  • Any neuropsychiatric illness, including substance abuse.
  • Any medical or neurological disease likely to impact the central nervous system.
  • Subject has a metal implant, pacemaker or other contraindication for MRI or fMRI.
  • Currently being treated with any medication that affects the central nervous system.
  • Women currently pregnant, breastfeeding or of childbearing age not currently taking or not willing to use a reliable form of contraception.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Relationship Between Autonomic Central Nervous System Activation and Atrial Fibrillation: A Prospective Functional MRI Study (fMRI)

The fMRI study is a prospective study with the objective of evaluating the effects of the autonomic central nervous system on the regulation of heart rate in patients with atrial fibrillation (AF). This study will compare a functional MRI (fMRI) scan in patients prior to a direct current cardioversion (DCCV) to a second fMRI scan taken post DCCV. In addition, this study will compare functional MRI (fMRIs) to a control group of heart healthy, age-matched patients who will also receive two fMRI scans spaced about one week apart.

Our expectation is that at the end of this study, the investigators will have greater insight into the role of the central nervous system and more specifically the autonomic nervous system in modulating AF. The investigators expect that understanding the interaction between the central nervous system and cardiac arrhythmias will lead to the development of novel therapies that preserve and restore normal sinus rhythm. This study will serve as a pilot study with the goal of obtaining additional grant funding and expanding the study once differences in volumes of activation are demonstrated.

Read the detailed description

The central nervous system (CNS) consists of the brain and spinal cord and serves as the collection point of nerve impulses. The peripheral nervous system (PNS) includes all nerves not in the brain or spinal cord and connects all parts of the body to the CNS. The autonomic nervous system (ANS), which consists mostly motor nerves, controls functions of involuntary smooth muscles, glands, and cardiac muscles. The ANS is further divided into the sympathetic and parasympathetic systems. In relation to the heart, the sympathetic system controls increases in heart rate, blood pressure, and cardiac output. The parasympathetic system lowers heart activity and operates during normal situations where the body is not under stress1, 2.

While the influence of the central nervous system on cardiac rhythm and function is well accepted, the mechanisms of this control are poorly understood. A preponderance of data implicates the autonomic nervous system in the development of many cases of atrial fibrillation (AF)3, 4. The importance of investigating the role of the central nervous system in the control of the heart rhythm can be appreciated when reviewing the prevalence of cardiac arrhythmias. AF alone affects 2.2 million adults in the United States. With the growing aged population, this number can be expected to rise to 5.6-10 million by the year 2050. AF contributes to the development of heart failure and stroke and can precipitate angina in some patients. New therapies are needed since both surgical and minimally invasive ablative techniques are associated with a substantial failure rate in addition to the complications of invasive procedures. Understanding the CNS's role promises to direct new therapies to improve treatment success and reduce complications associated with therapy for AF and other arrhythmias.

Direct current (DC) cardioversion (DCCV) is a procedure in which a synchronized electrical shock is delivered through the chest to the heart via electrodes that are applied to the skin of the chest and back. Most elective cardioversion procedures are performed to treat AF or atrial flutter (AFL). The shock causes all the heart cells to contract simultaneously, thereby interrupting and terminating the abnormal electrical rhythm of AF without damaging the heart. This interruption of the abnormal beat allows the electrical system in the heart to regain control and restore a normal sinus rhythm (see Figure 1, Appendix A). Since the shock can be painful, the patient is usually sedated. Once sedated, the physician charges the defibrillator to a specified energy level and then delivers the shock. Additional shocks at higher energy levels can be delivered if the first attempt does not restore sinus rhythm. Typically patients are able to go home about an hour after the procedure. DCCV will restore normal sinus rhythm in 90% of patients5.

Newer MRI techniques offer the ability to not only image anatomy, but also to assess brain activation patterns. Functional magnetic resonance imaging (fMRI) was developed in the early 1990s, and is a variation of magnetic resonance imaging (MRI). The primary purpose of fMRI is to observe brain function under varying stimuli in a non-invasive way. fMRI uses a conventional MRI scanner. It takes advantage of the magnetic properties of iron in the blood. Whenever any part of the brain becomes active, the small blood vessels in that localized region dilate, causing more blood to rush into that region of the brain. The blood's iron atoms cause small distortions in the magnetic field around them, which causes the MRI scanner to be able to read and display an image of the brain's activity. When a region of the brain is activated, a large amount of freshly oxygenated blood pours into that structure of the brain, thus causing a small change in the magnetic field, and producing an MRI signal in the active region6.

Prior studies have utilized heart rate variation or galvanic skin response as an independent measure of autonomic arousal and compared these measures to fMRI to determine regions of the brain that are active during sympathetic or parasympathetic arousal 7-11. Studies have typically identified activation within the anterior cingulate region and insular cortex during sympathetic activation and in the ventral anterior cingulate in parasympathetic activation12, 13. Moreover, attenuation of the parasympathetic myocardial innervations by myocardial fat pad or ablation of parasympathetic ganglionic plexi have been shown to suppress AF in a significant number of patients presenting with this arrhythmia14, 15. Whether attenuation of the central autonomic pathways plays a role in initiating AF, or if atrial arrhythmias may lead to this central attenuation is an open question. This study is aimed at defining the effect of AF on the central autonomic pathways and vise versa.

Our expectation is that at the end of this study, we will have greater insight into the role of the central nervous system and more specifically the autonomic nervous system in modulating AF. We expect that understanding the interaction between the central nervous system and cardiac arrhythmias will lead to the development of novel therapies that preserve and restore normal sinus rhythm.

This study will serve as a pilot study with the goal of obtaining additional grant funding and expanding the study once differences in volumes of activation are demonstrated.

Keywords
Atrial Fibrillation, fMRI
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02524028
Study groupRoleWhat they receive
Case Participant CohortParticipants with atrial fibrillation
Control Participant CohortParticipants without atrial fibrillation or any other heart disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre- and post- cardioversion fMRI scans will be compared

    Measured: fMRI pre cardioversion and fMRI within a week of cardioversion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2015 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02524028
Sponsor's protocol ID
IRB_00044089
Acronym
fMRI
Status last verified
Aug 2015
First submitted
17 Sep 2013
Last updated
14 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre- and post- cardioversion fMRI scans will be compared (time frame: fMRI pre cardioversion and fMRI within a week of cardioversion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.

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