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Physical and Psychological Health Trajectories in the Context of Coronary Heart Disease

NCT ID: NCT04433832

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Panic Disorder Generalized Anxiety Disorder Coronary Artery Disease Anxiety Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Quebec Heart Institute

OTHER

Sponsor Role collaborator

CISSS de Chaudière-Appalaches

OTHER_GOV

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Guillaume Foldes-Busque

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guillaume Foldes-Busque, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Quebec Heart and Lung Institute/Institut universitaire de cardiologie et de pneumologie de Québec

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jessica Lebel, M.A

Role: CONTACT

[email protected]
(418)656-2131 ext. 405068

Guillaume Foldes-Busque, Ph.D.

Role: CONTACT

[email protected]
418-656-2131 ext. 402592

Facility Contacts

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Guillaume Foldes-Busque, Ph.D.

Role: primary

[email protected]
418-656-2131 ext. 402592

Jessica Lebel, M.A.

Role: backup

[email protected]
418-6562131 ext. 405068

Other Identifiers

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LavalU

Identifier Type: -

Identifier Source: org_study_id