<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433832</url>
  </required_header>
  <id_info>
    <org_study_id>LavalU</org_study_id>
    <nct_id>NCT04433832</nct_id>
  </id_info>
  <brief_title>Physical and Psychological Health Trajectories in the Context of Coronary Heart Disease</brief_title>
  <official_title>Epidemiology and Prognostic Implications of Panic Disorder and Generalized Anxiety Disorder in Patients With Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quebec Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CISSS de Chaudière-Appalaches</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to establish how frequently patients with coronary artery&#xD;
      disease present or develop two anxiety disorders (panic disorder and generalized anxiety&#xD;
      disorder) in the two years following a medical intervention for their heart. A second&#xD;
      objective is to assess the impact of these anxiety disorders on the health of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery disease (CAD), the most common form of cardiovascular disease, affects&#xD;
      approximately 1 in 12 adults in Canada. CAD is a major public health concern and is one of&#xD;
      the costliest chronic diseases in North America. Up to 90% of the CAD risk is attributable to&#xD;
      nine modifiable risk factors, including psychosocial factors. Decades of research confirmed&#xD;
      the importance of psychosocial factors in the development, prognosis and clinical&#xD;
      presentation of CAD. One understudied but highly significant psychosocial risk factor is&#xD;
      anxiety. Prevalence estimates of anxiety disorders in patients with CAD range from 10% to&#xD;
      65%, with panic disorder (PD) and generalized anxiety disorder (GAD) being the most&#xD;
      prevalent. Both PD and GAD have been independently associated with a 36% to 94% increase in&#xD;
      the risk of adverse cardiac events in patients with CAD. However, these findings remain&#xD;
      controversial as some studies reported either an inverse or no association between PD and&#xD;
      adverse events. Still, both PD and GAD are associated with the presence of multiple risk&#xD;
      factors for CAD (e.g. smoking, high alcohol consumption and a sedentary lifestyle). These&#xD;
      anxiety disorders are also likely to influence medication taking behaviors as well as&#xD;
      adherence to cardiac rehabilitation programs. These data highlight the importance and&#xD;
      prognostic significance of PD/GAD in patients with CAD. However, considering the&#xD;
      contradictory data and significant methodological issues in the available studies, notably in&#xD;
      terms of the validity of PD and GAD diagnoses, new, methodologically sound studies are needed&#xD;
      to improve our understanding of this clinical problem and improve patient care.&#xD;
&#xD;
      The primary aim of this study is to establish the prevalence and incidence of PD and GAD in&#xD;
      the two years following a revascularization procedure for CAD. The secondary aim is to&#xD;
      prospectively assess the association between these disorders and cardiac mortality, adverse&#xD;
      cardiac events, adherence to recommended treatments (exercise, cardiac rehabilitation,&#xD;
      pharmacotherapy),quality of life and psychological distress.&#xD;
&#xD;
      This prospective cohort study will include 3610 patients who will be consecutively recruited&#xD;
      following a revascularisation procedure for CAD at the cardiology department of the Quebec&#xD;
      Heart and Lung Institute. Patients will be assessed at baseline (within a week of admission)&#xD;
      as well as 3, 6, 12 and 24 months later. PD and GAD will be assessed with a standardized and&#xD;
      validated semi-structured interview. The presence of adverse events, adherence to treatments,&#xD;
      psychological distress and quality of life will be assessed through a review of medical&#xD;
      records, questionnaires and interviews.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 20, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety and Related Disorders Interview Schedule for DSM-5</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse cardiac events</measure>
    <time_frame>2 years</time_frame>
    <description>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.&#xD;
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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study Measures of Patient Adherence</measure>
    <time_frame>2 years</time_frame>
    <description>A 5-item general measure which assesses the patients' tendency to comply with medical recommendations and a second section which measures adherence to recommendations made by a healthcare professional (e.g., taking medication, following a diet) in the context of CAD. Total scores range from 0 to 25, higher scores indicate higher reported medication adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence Scale in Chronic Diseases</measure>
    <time_frame>2 years</time_frame>
    <description>This measure specifically assesses medication adherence and some of its potential barriers in patients with CAD or other chronic diseases. Total scores range from 0 to 32, higher scores indicate higher reported medication adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac rehabilitation participation</measure>
    <time_frame>2 years</time_frame>
    <description>Patients will be asked if they participated in a formal rehabilitation program at each time point with two validated interview items. Attendance will be assessed by reviewing records of the 12-week cardiac rehabilitation programs. With written permission from patients or next of kin, records of attendance to programs outside of the study hospitals will be obtained from archives departments. Participation will be categorized as follows:&#xD;
Non-attendance: patients who did not attend a cardiac rehabilitation program.&#xD;
Level of adherence: calculated with the percentage of the prescribed sessions attended during the program.&#xD;
Completion: patients who attended at least 70% of the planned sessions.&#xD;
Discontinuation: patients who stopped attending cardiac rehabilitation at least 3 weeks before the end of the program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviors - Level of physical activity</measure>
    <time_frame>2 years</time_frame>
    <description>Level of physical activity: This parameter will be assessed with the validated French version of the International Physical Activity Questionnaire - Short Form. This questionnaire generates an average amount of time spent per week doing physical activity across activity domains. A higher mean time represents more physical activity on average.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviors - Smoking status</measure>
    <time_frame>2 years</time_frame>
    <description>Smoking status: This variable will be assessed using the validated self-report items developed by Statistics Canada to assess the current smoking status. Smoking status will be established based on the patients' self-reported smoking behaviour in the 30 days preceding each time point. Participants can be categorized as Non-Smokers, Occasional-Smokers or Regular Smokers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviors - Alcohol use</measure>
    <time_frame>2 years</time_frame>
    <description>Alcohol use: The patients' compliance with recommendations regarding alcohol consumption will be assessed with the first 3 items of the validated French version of the Alcohol Use Disorders Identification Test. Total scores range from 0 to 12, higher scores indicate higher alcohol use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviors - Fruit and vegetable intake</measure>
    <time_frame>2 years</time_frame>
    <description>Fruit and vegetable intake: Patients' usual consumption of fruit and vegetables will be assessed using the 6-item Fruit and Vegetable Questionnaire (FV-Q) validated questionnaire. This questionnaire generates a mean daily consumption of fruits and vegetables. A higher mean represents more servings consumed for each specific category.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and psychological distress - Health-related quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>Health-related quality of life: The 12-item Short-Form Health Survey Version 2 (SF-12v2) will be used to assess patients Health-related quality of life.&#xD;
Total scores range between 0 and 100, with higher scores indicating a better HRQOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and psychological distress - Anxiety and depressive symptoms</measure>
    <time_frame>2 years</time_frame>
    <description>Anxiety and depressive symptoms will be measured with the validated French version of the Hospital Anxiety and Depression Scale.&#xD;
Total scores range between 0 and 21, with higher scores indicating a higher level of anxiety/depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and psychological distress - Heart- focused anxiety</measure>
    <time_frame>2 years</time_frame>
    <description>Heart- focused anxiety will be assessed with the French version of the Cardiac Anxiety Questionnaire. Total scores range between 0 and 20, with higher scores indicating a higher level of heart-focused anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist for DSM-5</measure>
    <time_frame>2 years</time_frame>
    <description>The PCL-5 is a 20-item self-report questionnaire that assesses post-traumatic stress disorder (PTSD) symptoms according to DSM-5 criteria. In this study, the PCL will be used to assess symptom severity and to make a provisional PTSD diagnosis.&#xD;
Total scores range between 0 and 80, with higher scores indicating a higher level of PTSD.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sociodemographic data</measure>
    <time_frame>2 years</time_frame>
    <description>Sociodemographic information, including employment status, educational level and family income (i.e. socio-economic status), will be obtained using a brief questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Medical comorbidities and medical risk factors for CAD</measure>
    <time_frame>2 years</time_frame>
    <description>These data will be obtained through a medical interview and structured review of medical records. Obesity will be assessed using body mass index, which will be computed from the reported height and weight of patients obtained during the medical interview (kg/m2).</description>
  </other_outcome>
  <other_outcome>
    <measure>Other psychosocial risk factors for CAD - Social support</measure>
    <time_frame>2 years</time_frame>
    <description>Social support will be assessed with the validated French version of the Modified MOS Social Support Survey. This questionnaire generates two distinct subscales, emotional and instrumental support. Each subscale score ranges from 0 to 20, with higher scores representing more perceived support.</description>
  </other_outcome>
  <other_outcome>
    <measure>Other psychosocial risk factors for CAD - Depression, agoraphobia, health anxiety and somatic symptom disorders</measure>
    <time_frame>2 years</time_frame>
    <description>Depression, agoraphobia, health anxiety and somatic symptom disorders will be assessed with the ADIS-5.</description>
  </other_outcome>
  <enrollment type="Anticipated">3610</enrollment>
  <condition>Panic Disorder</condition>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Anxiety Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults patients who write and speak French and who have undergone a revascularization&#xD;
        procedure (percutaneous coronary intervention or coronary bypass grafting) for CAD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (18 years of age or older) who undergo a revascularization&#xD;
             procedure for CAD at the Quebec Heart and Lung Institute and who write/speak French&#xD;
             will be eligible for study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they present a severe communication problem or suffer&#xD;
             from a terminal illness, a diagnosed major cognitive deficit, or any other condition&#xD;
             that could invalidate the interview (e.g. psychotic disorder).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume Foldes-Busque, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Lebel, M.A</last_name>
    <phone>(418)656-2131</phone>
    <phone_ext>405068</phone_ext>
    <email>jessica.lebel@psy.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guillaume Foldes-Busque, Ph.D.</last_name>
    <phone>418-656-2131</phone>
    <phone_ext>402592</phone_ext>
    <email>guillaume.foldes-busque@psy.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Quebec Heart and Lung Institute/Institut universitaire de cardiologie et de pneumologie de Québec</name>
      <address>
        <city>Québec</city>
        <zip>G1V4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guillaume Foldes-Busque, Ph.D.</last_name>
      <phone>418-656-2131</phone>
      <phone_ext>402592</phone_ext>
      <email>guillaume.foldes-busque@psy.ulaval.ca</email>
    </contact>
    <contact_backup>
      <last_name>Jessica Lebel, M.A.</last_name>
      <phone>418-6562131</phone>
      <phone_ext>405068</phone_ext>
      <email>jessica.lebel@psy.ulaval.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Guillaume Foldes-Busque</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Anxiety disorders</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Cardiac rehabilitation</keyword>
  <keyword>Psychosocial risk factors</keyword>
  <keyword>Health behaviors</keyword>
  <keyword>Treatment adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433832
org study id: LavalU
nct id: NCT04433832
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Anxiety and Related Disorders Interview Schedule for DSM-5
time frame: 2 years
description: 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.
measure: Adverse cardiac events
time frame: 2 years
description: 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).
measure: Medical Outcomes Study Measures of Patient Adherence
time frame: 2 years
description: A 5-item general measure which assesses the patients' tendency to comply with medical recommendations and a second section which measures adherence to recommendations made by a healthcare professional (e.g., taking medication, following a diet) in the context of CAD. Total scores range from 0 to 25, higher scores indicate higher reported medication adherence.
measure: Adherence Scale in Chronic Diseases
time frame: 2 years
description: This measure specifically assesses medication adherence and some of its potential barriers in patients with CAD or other chronic diseases. Total scores range from 0 to 32, higher scores indicate higher reported medication adherence.
measure: Cardiac rehabilitation participation
time frame: 2 years
description: Patients will be asked if they participated in a formal rehabilitation program at each time point with two validated interview items. Attendance will be assessed by reviewing records of the 12-week cardiac rehabilitation programs. With written permission from patients or next of kin, records of attendance to programs outside of the study hospitals will be obtained from archives departments. Participation will be categorized as follows:
Non-attendance: patients who did not attend a cardiac rehabilitation program.
Level of adherence: calculated with the percentage of the prescribed sessions attended during the program.
Completion: patients who attended at least 70% of the planned sessions.
Discontinuation: patients who stopped attending cardiac rehabilitation at least 3 weeks before the end of the program.
measure: Health behaviors - Level of physical activity
time frame: 2 years
description: Level of physical activity: This parameter will be assessed with the validated French version of the International Physical Activity Questionnaire - Short Form. This questionnaire generates an average amount of time spent per week doing physical activity across activity domains. A higher mean time represents more physical activity on average.
measure: Health behaviors - Smoking status
time frame: 2 years
description: Smoking status: This variable will be assessed using the validated self-report items developed by Statistics Canada to assess the current smoking status. Smoking status will be established based on the patients' self-reported smoking behaviour in the 30 days preceding each time point. Participants can be categorized as Non-Smokers, Occasional-Smokers or Regular Smokers.
measure: Health behaviors - Alcohol use
time frame: 2 years
description: Alcohol use: The patients' compliance with recommendations regarding alcohol consumption will be assessed with the first 3 items of the validated French version of the Alcohol Use Disorders Identification Test. Total scores range from 0 to 12, higher scores indicate higher alcohol use.
measure: Health behaviors - Fruit and vegetable intake
time frame: 2 years
description: Fruit and vegetable intake: Patients' usual consumption of fruit and vegetables will be assessed using the 6-item Fruit and Vegetable Questionnaire (FV-Q) validated questionnaire. This questionnaire generates a mean daily consumption of fruits and vegetables. A higher mean represents more servings consumed for each specific category.
measure: Quality of life and psychological distress - Health-related quality of life
time frame: 2 years
description: Health-related quality of life: The 12-item Short-Form Health Survey Version 2 (SF-12v2) will be used to assess patients Health-related quality of life.
Total scores range between 0 and 100, with higher scores indicating a better HRQOL.
measure: Quality of life and psychological distress - Anxiety and depressive symptoms
time frame: 2 years
description: Anxiety and depressive symptoms will be measured with the validated French version of the Hospital Anxiety and Depression Scale.
Total scores range between 0 and 21, with higher scores indicating a higher level of anxiety/depression.
measure: Quality of life and psychological distress - Heart- focused anxiety
time frame: 2 years
description: Heart- focused anxiety will be assessed with the French version of the Cardiac Anxiety Questionnaire. Total scores range between 0 and 20, with higher scores indicating a higher level of heart-focused anxiety.
measure: PTSD Checklist for DSM-5
time frame: 2 years
description: The PCL-5 is a 20-item self-report questionnaire that assesses post-traumatic stress disorder (PTSD) symptoms according to DSM-5 criteria. In this study, the PCL will be used to assess symptom severity and to make a provisional PTSD diagnosis.
Total scores range between 0 and 80, with higher scores indicating a higher level of PTSD.
measure: Sociodemographic data
time frame: 2 years
description: Sociodemographic information, including employment status, educational level and family income (i.e. socio-economic status), will be obtained using a brief questionnaire.
measure: Medical comorbidities and medical risk factors for CAD
time frame: 2 years
description: These data will be obtained through a medical interview and structured review of medical records. Obesity will be assessed using body mass index, which will be computed from the reported height and weight of patients obtained during the medical interview (kg/m2).
measure: Other psychosocial risk factors for CAD - Social support
time frame: 2 years
description: Social support will be assessed with the validated French version of the Modified MOS Social Support Survey. This questionnaire generates two distinct subscales, emotional and instrumental support. Each subscale score ranges from 0 to 20, with higher scores representing more perceived support.
measure: Other psychosocial risk factors for CAD - Depression, agoraphobia, health anxiety and somatic symptom disorders
time frame: 2 years
description: Depression, agoraphobia, health anxiety and somatic symptom disorders will be assessed with the ADIS-5.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume Foldes-Busque, Ph.D.
role: Principal Investigator
affiliation: Laval University
last name: Jessica Lebel, M.A
phone: (418)656-2131
phone ext: 405068
email: jessica.lebel@psy.ulaval.ca
last name: Guillaume Foldes-Busque, Ph.D.
phone: 418-656-2131
phone ext: 402592
email: guillaume.foldes-busque@psy.ulaval.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Guillaume Foldes-Busque
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Anxiety Disorders
mesh term: Panic Disorder
sharing ipd: No