Epidemiology and Prognostic Implications of Panic Disorder and Generalized Anxiety Disorder in Patients With Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Laval University
- Enrollment
- 3,610
- Locations
- 1
- Primary Endpoint
- Anxiety and Related Disorders Interview Schedule for DSM-5
Study Overview
Brief Summary
The primary aim of this study is to establish how frequently patients with coronary artery disease present or develop two anxiety disorders (panic disorder and generalized anxiety disorder) in the two years following a medical intervention for their heart. A second objective is to assess the impact of these anxiety disorders on the health of these patients.
Detailed Description
Coronary artery disease (CAD), the most common form of cardiovascular disease, affects approximately 1 in 12 adults in Canada. CAD is a major public health concern and is one of the costliest chronic diseases in North America. Up to 90% of the CAD risk is attributable to nine modifiable risk factors, including psychosocial factors. Decades of research confirmed the importance of psychosocial factors in the development, prognosis and clinical presentation of CAD. One understudied but highly significant psychosocial risk factor is anxiety. Prevalence estimates of anxiety disorders in patients with CAD range from 10% to 65%, with panic disorder (PD) and generalized anxiety disorder (GAD) being the most prevalent. Both PD and GAD have been independently associated with a 36% to 94% increase in the risk of adverse cardiac events in patients with CAD. However, these findings remain controversial as some studies reported either an inverse or no association between PD and adverse events. Still, both PD and GAD are associated with the presence of multiple risk factors for CAD (e.g. smoking, high alcohol consumption and a sedentary lifestyle). These anxiety disorders are also likely to influence medication taking behaviors as well as adherence to cardiac rehabilitation programs. These data highlight the importance and prognostic significance of PD/GAD in patients with CAD. However, considering the contradictory data and significant methodological issues in the available studies, notably in terms of the validity of PD and GAD diagnoses, new, methodologically sound studies are needed to improve our understanding of this clinical problem and improve patient care.
The primary aim of this study is to establish the prevalence and incidence of PD and GAD in the two years following a revascularization procedure for CAD. The secondary aim is to prospectively assess the association between these disorders and cardiac mortality, adverse cardiac events, adherence to recommended treatments (exercise, cardiac rehabilitation, pharmacotherapy),quality of life and psychological distress.
This prospective cohort study will include 3610 patients who will be consecutively recruited following a revascularisation procedure for CAD at the cardiology department of the Quebec Heart and Lung Institute. Patients will be assessed at baseline (within a week of admission) as well as 3, 6, 12 and 24 months later. PD and GAD will be assessed with a standardized and validated semi-structured interview. The presence of adverse events, adherence to treatments, psychological distress and quality of life will be assessed through a review of medical records, questionnaires and interviews.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients (18 years of age or older) who undergo a revascularization procedure for CAD at the Quebec Heart and Lung Institute and who write/speak French will be eligible for study participation.
Exclusion Criteria
- •Patients will be excluded if they present a severe communication problem or suffer from a terminal illness, a diagnosed major cognitive deficit, or any other condition that could invalidate the interview (e.g. psychotic disorder).
Outcomes
Primary Outcomes
Anxiety and Related Disorders Interview Schedule for DSM-5
Time Frame: 2 years
Panic disorder (PD) and generalized anxiety disorder (GAD) will be assessed at each time point using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5). This standardized interview protocol is one of the recommended measures for diagnosing anxiety disorders, including PD and GAD, in the research context. The PD and GAD modules of previous versions of the ADIS have demonstrated excellent reliability for their respective diagnoses.
Adverse cardiac events
Time Frame: 2 years
Patients will be asked about all potential adverse events during a structured medical interview developed by our team. All data will be confirmed by a review of medical records. With written permission from patients or next of kin (if deceased), records for admissions or consultations outside of the study hospitals will be obtained from the establishment archives. Medical data will be extracted by the research nurses using a standardized medical data extraction form known for its excellent reliability. Adverse events are defined as: either an acute myocardial infarction, a revascularization procedure (percutaneous coronary intervention or coronary bypass grafting), a cardiac arrest (including ventricular fibrillation) or death from a cardiovascular cause (primary cause).
Secondary Outcomes
- Adherence Scale in Chronic Diseases(2 years)
- Cardiac rehabilitation participation(2 years)
- Health behaviors - Level of physical activity(2 years)
- Quality of life and psychological distress - Health-related quality of life(2 years)
- Medical Outcomes Study Measures of Patient Adherence(2 years)
- Health behaviors - Smoking status(2 years)
- Health behaviors - Alcohol use(2 years)
- Quality of life and psychological distress - Anxiety and depressive symptoms(2 years)
- Health behaviors - Fruit and vegetable intake(2 years)
- Quality of life and psychological distress - Heart- focused anxiety(2 years)
- PTSD Checklist for DSM-5(2 years)
Investigators
Guillaume Foldes-Busque
Professor
Laval University
