The Relationship Between Panic Attack Symptoms and Atrial Fibrillation Episodes.

NCT04634461 | Terminated FDA Device

• 1 other identifier: 00004983
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

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; Symptom monitoring; Stress

Outcome Measures

Primary Outcomes (3)

• Ecological momentary assessments of atrial fibrillation symptoms

  Self reporting of atrial fibrillation symptoms

  repeated measures throughout the 4 week protocol

• Ecological momentary assessments of anxiety

  Self reporting of anxiety symptoms

  repeated measures throughout the 4 week protocol

• Mobile cardiac event recorder

  EKG

  repeated measures throughout the 4 week protocol

Interventions

Cardiac Monitor DEVICE

RHYTHMSTAR Mobile Cardiac Monitoring System

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Academic Cardiology Practice

You may qualify if:

• 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.

You may not qualify if:

• 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%
• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Panic Disorder; Anxiety Disorders; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Anne Curtis, MD

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor, Charles and Mary Bauer Professor and Chair, Dept of Medicine

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: March 15, 2021
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)