Atrial Fibrillation ParoxysmalNCT04634461
The Relationship Between Panic Attack Symptoms and Atrial Fibrillation Episodes.
An observational study of Atrial Fibrillation Paroxysmal and Panic, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
To characterize the relationship between panic attack symptoms and atrial fibrillation episodes using a real-time assessment data capturing system that reduces recall biases of previous research. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Panic, Panic Disorder
- What is being tested?
- Cardiac Monitor
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 7 Apr 2025
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Academic Cardiology Practice
Who may be able to join
- Patients (male and female) between 21 - 75 years of age
- Patients of both sexes, of varying races and ethnicities, with a range of educational levels and ages
- ICD-10 diagnosis code of PAF in the electronic medical record or ECG demonstrating PAF in the chart.
- History of PA symptoms as identified on screening with the PHQ-PD
- Read and speak English
- Access to a smartphone and internet/data coverage.
- Ability to read and type within a smartphone-based application.
- Capacity to understand and provide informed consent, and comply with protocol requirements that includes completion of a limited number of questionnaires.
Who cannot join
- Uncontrolled hypertension (defined as documented BP readings consistently above 140/90)
- Patients younger than 21 years old or older than 75 years old
- Reversible causes of AF, which include but are not limited to untreated thyroid disease, recent major surgical procedure or trauma, etc
- History of persistent or chronic AF
- History of clinically significant valvular heart disease (bio prosthetic or mechanical valve, severe aortic stenosis, moderate to severe mitral stenosis, rheumatic heart disease, or severe mitral regurgitation)
- History of congestive heart failure (CHF) and an ejection fraction (EF) of less than 40%
Show all 23Show fewer
- History of new onset coronary artery disease (CAD) in the last 90 days
- History of myocardial infarction (MI) in the last 90 days
- History of percutaneous coronary intervention in the last 90 days
- History of coronary artery bypass grafting in the last 90 days.
- History of untreated obstructive sleep apnea (OSA)
- History of severe pulmonary hypertension
- Patients on rhythm control medications and expected to have changing dose during the study (not excluded if patient anticipated to be on stable dose throughout duration of the study: 30 days).
- History of cerebrovascular injury (stroke, transient ischemic attack, traumatic brain injury) in the last 90 days
- Morbid obesity, Body Mass Index (BMI) >40 kg/m2
- Dementia or any form of cognitive impairment that precludes the patient from providing consent
- Pregnant women
- Patients with a major psychiatric disorder which, in the opinion of the investigator, may impede his/her participation in the study. These disorders include, but are not limited to, major depression with high likelihood of suicidal behavior (i.e., intent or plan), alcohol or substance abuse/dependence within the past year, lifetime history of schizophrenia or schizoaffective disorder, psychoses, mania.
- Patients who do not have a smartphone device
- Uncompensated hearing or visual defects
- Patients unable to communicate verbally in English
- Patients who are unable to fully comprehend the consent forms
- Medically unstable patients or patients who have a life expectancy less than the anticipated duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
To characterize the relationship between panic attack symptoms and atrial fibrillation episodes using a real-time assessment data capturing system that reduces recall biases of previous research.
Read the detailed description
Atrial fibrillation (AF) is a major health care problem) whose cardiac symptoms often overlap with panic attack (PA) symptoms. This pattern of comorbidity is important because it may delay accurate diagnosis, influence medical decision making, compromise physician-patient relationship, and reinforce illness behaviors. Clarifying the temporal relationship between panic and AF symptoms may create opportunities for more effective disease management programs.
The purpose of this study is to characterize the temporal relationship between PA symptoms and AF episodes using a real-time assessment data capturing system that has methodological advantages over retrospective designs in previous research.
Local cardiology practices will be screened for patients aged 21-75 years with paroxysmal AF for PA symptoms. Patients with AF indicating on the Patient Health Questionnaire (PHQ) a history of PA and experiencing at least one PA in the previous 4 weeks will be eligible. A formal diagnosis of panic disorder is not required.
Thirty individuals will be enrolled for 4 weeks, during which they will wear an external cardiac event monitor for continuous rhythm monitoring. A mobile internet based application will allow participants to complete a panic episode report when they experience PA symptoms. They will record the time and duration of each episode, fear, and the PA symptoms. At end of day, participants will record their daily emotions, AF and PA symptoms, and health behaviors. Daily reminders for episode and daily reports with be sent via text message. Cardiac monitoring data, evening reports, and panic episode reports will be assessed by research staff daily.
The primary aim is to examine the correspondence of PA and AF episodes. A time-lagged hierarchical model with repeated measures will examine whether panic episodes immediately precede or follow episodes of AF (i.e., within 4 hours). Power to detect an effect was estimated based on Monte Carlo studies run in MPlus. Based on findings that anxiety attacks are associated with a 4-time greater likelihood of episodes of AF, we estimated an effect size of ß=.25. For episodes as infrequent as 3 out of 14 days on average (150 total observations) statistical power exceeds .80.
The hypothesis is that a percentage of individuals will show a temporal relationship between their PA symptoms and AF episodes and that this temporal relationship will differ among patients with disparate, but distinct, psychological/medical profiles.
Findings may be informative for cardiologists treating AF patients who experience PA symptoms and may suggest effective disease management programs that help patients self-manage anxiety-related AF symptoms. The study will also provide pilot data on the utility of our assessment procedures for use in larger more comprehensive externally funded studies.
- Conditions
- Atrial Fibrillation Paroxysmal, Panic, Panic Disorder, Panic Attacks
- Being tested
- Cardiac Monitor
- Keywords
- Anxiety, Panic attack/ disorder, arrhythmias, Atrial Fibrillation, Cardiac Arrhythmia, Ecological momentary assessment, cardiac monitoring, Recall bias, Symptom monitoring, Stress
- Medical subject headings
- Atrial Fibrillation, Panic Disorder, Anxiety Disorders, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MonitorDevice
RHYTHMSTAR Mobile Cardiac Monitoring System
What is being measured
The primary outcome is the main question the study is designed to answer.
Ecological momentary assessments of atrial fibrillation symptoms
Self reporting of atrial fibrillation symptoms
Measured: repeated measures throughout the 4 week protocol
Ecological momentary assessments of anxiety
Self reporting of anxiety symptoms
Measured: repeated measures throughout the 4 week protocol
Mobile cardiac event recorder
EKG
Measured: repeated measures throughout the 4 week protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start15 Mar 2021
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Why it stopped: Unable to enroll the required number of subjects to achieve statistically significant results. There were no adverse events to report.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Curtis, State University of New York at Buffalo
- Investigators
- Anne Curtis, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634461
- Sponsor's protocol ID
- 00004983
- Status last verified
- Apr 2025
- First submitted
- 9 Nov 2020
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Panic Attack Symptoms and Atrial Fibrillation Episodes.
- ClinicalTrials.gov ID
- NCT04634461
- Acronym / sponsor ID
- 00004983
- Conditions
- Atrial Fibrillation Paroxysmal, Panic, Panic Disorder, Panic Attacks
- Keywords
- Anxiety, Panic attack/ disorder, arrhythmias, Atrial Fibrillation, Cardiac Arrhythmia, Ecological momentary assessment, cardiac monitoring, Recall bias
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to enroll the required number of subjects to achieve statistically significant results. There were no adverse events to report.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 18 Nov 2020 (actual)
- 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.
To characterize the relationship between panic attack symptoms and atrial fibrillation episodes using a real-time assessment data capturing system that reduces recall biases of previous research.
Detailed description
Atrial fibrillation (AF) is a major health care problem) whose cardiac symptoms often overlap with panic attack (PA) symptoms. This pattern of comorbidity is important because it may delay accurate diagnosis, influence medical decision making, compromise physician-patient relationship, and reinforce illness behaviors. Clarifying the temporal relationship between panic and AF symptoms may create opportunities for more effective disease management programs.
The purpose of this study is to characterize the temporal relationship between PA symptoms and AF episodes using a real-time assessment data capturing system that has methodological advantages over retrospective designs in previous research.
Local cardiology practices will be screened for patients aged 21-75 years with paroxysmal AF for PA symptoms. Patients with AF indicating on the Patient Health Questionnaire (PHQ) a history of PA and experiencing at least one PA in the previous 4 weeks will be eligible. A formal diagnosis of panic disorder is not required.
Thirty individuals will be enrolled for 4 weeks, during which they will wear an external cardiac event monitor for continuous rhythm monitoring. A mobile internet based application will allow participants to complete a panic episode report when they experience PA symptoms. They will record the time and duration of each episode, fear, and the PA symptoms. At end of day, participants will record their daily emotions, AF and PA symptoms, and health behaviors. Daily reminders for episode and daily reports with be sent via text message. Cardiac monitoring data, evening reports, and panic episode reports will be assessed by research staff daily.
The primary aim is to examine the correspondence of PA and AF episodes. A time-lagged hierarchical model with repeated measures will examine whether panic episodes immediately precede or follow episodes of AF (i.e., within 4 hours). Power to detect an effect was estimated based on Monte Carlo studies run in MPlus. Based on findings that anxiety attacks are associated with a 4-time greater likelihood of episodes of AF, we estimated an effect size of ß=.25. For episodes as infrequent as 3 out of 14 days on average (150 total observations) statistical power exceeds .80.
The hypothesis is that a percentage of individuals will show a temporal relationship between their PA symptoms and AF episodes and that this temporal relationship will differ among patients with disparate, but distinct, psychological/medical profiles.
Findings may be informative for cardiologists treating AF patients who experience PA symptoms and may suggest effective disease management programs that help patients self-manage anxiety-related AF symptoms. The study will also provide pilot data on the utility of our assessment procedures for use in larger more comprehensive externally funded studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Academic Cardiology Practice
Key inclusion criteria (8 listed)
- Patients (male and female) between 21 - 75 years of age
- Patients of both sexes, of varying races and ethnicities, with a range of educational levels and ages
- ICD-10 diagnosis code of PAF in the electronic medical record or ECG demonstrating PAF in the chart.
- History of PA symptoms as identified on screening with the PHQ-PD
- Read and speak English
Key exclusion criteria (23 listed)
- Uncontrolled hypertension (defined as documented BP readings consistently above 140/90)
- Patients younger than 21 years old or older than 75 years old
- Reversible causes of AF, which include but are not limited to untreated thyroid disease, recent major surgical procedure or trauma, etc
- History of persistent or chronic AF
- History of clinically significant valvular heart disease (bio prosthetic or mechanical valve, severe aortic stenosis, moderate to severe mitral stenosis, rheumatic heart disease, or severe mitral regurgitation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MonitorRHYTHMSTAR Mobile Cardiac Monitoring System | Device | – |
Primary outcome
Ecological momentary assessments of atrial fibrillation symptoms
Time frame: repeated measures throughout the 4 week protocol
Self reporting of atrial fibrillation symptoms
Ecological momentary assessments of anxiety
Time frame: repeated measures throughout the 4 week protocol
Self reporting of anxiety symptoms
Mobile cardiac event recorder
Time frame: repeated measures throughout the 4 week protocol
EKG
Results and safety
The study was stopped early (reason given: Unable to enroll the required number of subjects to achieve statistically significant results. There were no adverse events to report.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Anne Curtis, MD principal investigator
State University of New York at Buffalo
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 Paroxysmal and Panic, run by State University of New York at Buffalo 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 8 inclusion and 23 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: stopped early, as of the sponsor's last update on 13 Apr 2025. 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 was stopped early (reason given: Unable to enroll the required number of subjects to achieve statistically significant results. There were no adverse events to report.). Results are not available in the source record.
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?
Ecological momentary assessments of atrial fibrillation symptoms (time frame: repeated measures throughout the 4 week protocol). The study lists 3 primary outcomes in all. 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 13 Apr 2025.