Panic Disorder Clinical Trial
Official title:
The Relationship Between Panic Attack Symptoms and Atrial Fibrillation Episodes.
Verified date | February 2024 |
Source | State University of New York at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | August 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University at Buffalo | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ecological momentary assessments of atrial fibrillation symptoms | Self reporting of atrial fibrillation symptoms | repeated measures throughout the 4 week protocol | |
Primary | Ecological momentary assessments of anxiety | Self reporting of anxiety symptoms | repeated measures throughout the 4 week protocol | |
Primary | Mobile cardiac event recorder | EKG | repeated measures throughout the 4 week protocol |
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