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.
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.
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.
- Conditions
- Atrial Fibrillation
- 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 group | Role | What they receive |
|---|---|---|
| Case Participant Cohort | Participants with atrial fibrillation | |
| Control Participant Cohort | Participants 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.
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.
- First posted14 Aug 2015 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassir F. Marrouche, MD, University of Utah
- Investigators
- Nassir F Marrouche, MD, FHRS, Principal investigator, University of Utah
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Autonomic Central Nervous System Activation and Atrial Fibrillation: A Prospective Functional MRI Study (fMRI)
- ClinicalTrials.gov ID
- NCT02524028
- Acronym / sponsor ID
- fMRI / IRB_00044089
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Participant Cohort | – | –Participants with atrial fibrillation |
| Control Participant Cohort | – | –Participants without atrial fibrillation or any other heart disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- AF patients presenting for DCCV
- Right-handed
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre- and post- cardioversion fMRI scans will be compared
Time frame: fMRI pre cardioversion and fMRI within a week of cardioversion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nassir F Marrouche, MD, FHRS principal investigator
University of Utah
1 site in 1 country: see every site and its status.
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.