Clinical trial NCT04433832: Physical and Psychological Health Trajectories in the Context of Coronary Heart Disease
Official title: Epidemiology and Prognostic Implications of Panic Disorder and Generalized Anxiety Disorder in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Panic Disorder
Generalized Anxiety Disorder
Coronary Artery Disease
Anxiety Disorders
Keywords: Coronary artery disease
Anxiety
Anxiety disorders
Prognosis
Cardiac rehabilitation
Psychosocial risk factors
Health behaviors
Treatment adherence
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Quebec Heart Institute
name: CISSS de Chaudière-Appalaches
First posted: 2020-06-16
Enrollment: 3610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults patients who write and speak French and who have undergone a revascularization procedure (percutaneous coronary intervention or coronary bypass grafting) for CAD.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Anxiety and Related Disorders Interview Schedule for DSM-5
timeFrame: 2 years
measure: Adverse cardiac events
timeFrame: 2 years
Secondary outcomes:
measure: Medical Outcomes Study Measures of Patient Adherence
timeFrame: 2 years
measure: Adherence Scale in Chronic Diseases
timeFrame: 2 years
measure: Cardiac rehabilitation participation
timeFrame: 2 years
measure: Health behaviors - Level of physical activity
timeFrame: 2 years
measure: Health behaviors - Smoking status
timeFrame: 2 years
measure: Health behaviors - Alcohol use
timeFrame: 2 years
measure: Health behaviors - Fruit and vegetable intake
timeFrame: 2 years
measure: Quality of life and psychological distress - Health-related quality of life
timeFrame: 2 years
measure: Quality of life and psychological distress - Anxiety and depressive symptoms
timeFrame: 2 years
measure: Quality of life and psychological distress - Heart- focused anxiety
timeFrame: 2 years
measure: PTSD Checklist for DSM-5
timeFrame: 2 years
Other outcomes:
measure: Sociodemographic data
timeFrame: 2 years
measure: Medical comorbidities and medical risk factors for CAD
timeFrame: 2 years
measure: Other psychosocial risk factors for CAD - Social support
timeFrame: 2 years
measure: Other psychosocial risk factors for CAD - Depression, agoraphobia, health anxiety and somatic symptom disorders
timeFrame: 2 years
Locations:
city: Québec
country: Canada
facility: Quebec Heart and Lung Institute/Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Laval University
name: Guillaume Foldes-Busque, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: