NCT04433832

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

May 28, 2020

Last Update Submit

October 29, 2020

Conditions

Panic DisorderGeneralized Anxiety DisorderCoronary Artery DiseaseAnxiety Disorders

Keywords

Coronary artery diseaseAnxietyAnxiety disordersPrognosisCardiac rehabilitationPsychosocial risk factorsHealth behaviorsTreatment adherence

Outcome Measures

Primary Outcomes (2)

  • Anxiety and Related Disorders Interview Schedule for DSM-5

    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.

    2 years

  • Adverse cardiac events

    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).

    2 years

Secondary Outcomes (11)

  • Medical Outcomes Study Measures of Patient Adherence

    2 years

  • Adherence Scale in Chronic Diseases

    2 years

  • Cardiac rehabilitation participation

    2 years

  • Health behaviors - Level of physical activity

    2 years

  • Health behaviors - Smoking status

    2 years

  • +6 more secondary outcomes

Other Outcomes (4)

  • Sociodemographic data

    2 years

  • Medical comorbidities and medical risk factors for CAD

    2 years

  • Other psychosocial risk factors for CAD - Social support

    2 years

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Panic DisorderGeneralized Anxiety DisorderCoronary Artery DiseaseAnxiety DisordersHealth BehaviorTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mental DisordersCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehavior

Study Officials

  • Guillaume Foldes-Busque, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Lebel, M.A

CONTACT

(418)656-2131jessica.lebel@psy.ulaval.ca

Guillaume Foldes-Busque, Ph.D.

CONTACT

418-656-2131guillaume.foldes-busque@psy.ulaval.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 16, 2020

Study Start

January 20, 2020

Primary Completion

June 30, 2022

Study Completion

November 30, 2023

Last Updated

October 30, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)