Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

NCT ID: NCT04752228

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-06-30

Brief Summary

Adverse Childhood Experiences (ACEs) are potentially harmful events occurring during childhood that have been associated with chronic physical conditions in adulthood, including coronary artery disease (CAD). ACEs may constitute a portion of the remaining unexplained residual risk for CAD in adults. Identifying a means of addressing these experiences may mitigate their health consequences and result in improved cardiovascular outcomes.

The primary objective of this study is to determine if patients who undergo ACE screening experience improved quality of life compared to patients who undergo conventional lifestyle assessment.

This will be a single-centre, pragmatic, single-blinded (i.e. data analysts), 1:1, pilot randomized control trial.

Detailed Description

ACEs encapsulate a broad spectrum of traumatic and distressing events occurring before the age of 18 that span the domains of abuse, household dysfunction, neglect, amongst others, and that threaten a child's physical, familial or social safety. The landmark ACE Study, published by Felitti and colleagues, was the first study to propose the association between ACEs and the development of chronic physical conditions in adulthood, including cardiovascular disease (CVD). Due to a variety of mechanisms, exposure to an ACE increases predisposition to the development of CVD and its conventional risk factors. ACEs nonetheless remain underrecognized and undermanaged in routine cardiovascular clinical encounters.

Integration of ACE screening into the standardized clinical assessment of CVD may enable cardiologists to better identify patients who might benefit from further post-ACE resiliency interventions and serve as an impactful secondary and tertiary prevention strategy. The ACE screening process itself may be therapeutic as it gives patients the opportunity to discuss their early experiences, reflect on the role of early adversity in their current health problems, and have some sympathetic acknowledgement about this history from a health care professional. This has been termed "ACE insight". Screening for ACEs has been found to be acceptable by patients. Patients may have never had any opportunity to discuss ACEs they have undergone throughout their entire life, enabling their effects to propagate into adulthood. Inquiring about ACE exposure during clinical encounters with all patients may garner insights that can have a beneficial effect in improving cardiovascular health. Additionally, engaging patients in stress-coping therapies, such as mindfulness, and referral for psychological consultation as needed, may also be helpful. Although logical, these strategies still lack adequate evidence and a randomized trial is needed to evaluate their potential in reducing the occurrence of cardiovascular events.

This study aims to assess whether deleterious childhood exposures are associated with an increased prevalence of risk factors for CAD and represent an independent risk factor for CAD. Furthermore, screening for ACEs in patients with CAD may serve as a therapeutic intervention in itself by providing both ACE insight and a platform to unload internal psychological burdens. Screening may result in an enhanced quality of life, as well as improved health behaviours that may benefit their cardiovascular outcomes.

Conditions

Adverse Childhood Experiences; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

ACE Screen

At the initial visit, the Philadelphia ACE Survey, a validated ACE questionnaire, will be administered by a research coordinator. A Lifestyle Assessment package will also be provided for self-completion, featuring General Demographics, Cardiovascular and Medication History, Health Behaviours, the Short Form (36) Health Survey, the Patient Health Questionnaire-9, the General Anxiety Disorder-7 questionnaire, the Seattle Angina Questionnaire-7, and the modified Perceived Need for Card Questionnaire. Patients who test positive for ACE will receive a 3-page printed ACE Resource Pack.

At 3 months, the Lifestyle Assessment will be administered again.

At 6 months, the Philadelphia ACE survey, Lifestyle Assessment, as well as a scale assessing their comfort level in being screened for ACE, disclosing their ACE status to their clinicians, and their confidence level in their clinicians' ability to help them manage their ACEs will be administered.

Group Type: EXPERIMENTAL

Philadelphia ACE Survey

Intervention Type: OTHER

The Philadelphia ACE survey assesses the three major domains featured within the original ACE Study Questionnaire developed by Felitti et al. (abuse, neglect, and family dysfunction), in addition to five community-level stressors.

Lifestyle Assessment

Intervention Type: OTHER

The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.

Lifestyle Assessment

At the initial visit, no Philadelphia ACE Survey will be administered. The Lifestyle Assessment packaged will be provided for self-completion, featuring General Demographics, Cardiovascular and Medication History, Health Behaviours, the Short Form (36) Health Survey, the Patient Health Questionnaire-9, the General Anxiety Disorder-7 questionnaire, the Seattle Angina Questionnaire-7, and the modified Perceived Need for Card Questionnaire.

At 3 months, the Lifestyle Assessment will be administered again.

At 6 months, the Philadelphia ACE survey, Lifestyle Assessment, as well as a scale assessing their comfort level in being screened for ACE, disclosing their ACE status to their clinicians, and their confidence level in their clinicians' ability to help them manage their ACEs will be administered.

Group Type: OTHER

Lifestyle Assessment

Intervention Type: OTHER

The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.

Interventions

Philadelphia ACE Survey

The Philadelphia ACE survey assesses the three major domains featured within the original ACE Study Questionnaire developed by Felitti et al. (abuse, neglect, and family dysfunction), in addition to five community-level stressors.

Intervention Type: OTHER

Lifestyle Assessment

The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years at screening

2. History of (1) acute coronary syndrome (ACS) OR (2) coronary artery disease (CAD) necessitating prior cardiovascular intervention. History of ACS determined by documentation of ST-elevation myocardial infarction or non-ST-segment elevation infarction 1-12 months prior to time of screening. History of CAD determined by documentation of percutaneous coronary intervention or coronary artery bypass surgery within the last 1-12 months.

3. Able to complete a survey independently

4. Access to a phone

5. Willingness to participate as evidenced by signing of the study informed consent form

Exclusion Criteria

1. Inability to speak, read and write in English

2. Cognitive impairment

3. Severe physical or mental illness

4. Limited life expectancy (projected to be less than 1 year)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Socar Research SA

NETWORK

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Michael Farkouh

Vice-Chair Research & Professor of Medicine, Department of Medicine, University of Toronto

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Farkouh, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network-Toronto General Hospital, Canada

Claudia Frankfurter, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network-Toronto General Hospital, Canada

Lucas C Godoy, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network-Toronto General Hospital, Canada

Christine Lay, MD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital, Canada

Robert Maunder, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Canada

Locations

Peter Munk Cardiac Centre - University Health Network

Toronto, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Michael Farkouh, MD

Role: CONTACT

michael.farkouh@uhn.ca

416-340-3141

Amanda Garrioch

Role: CONTACT

amanda.garrioch@uhn.ca

416-340-4800 ext. 2746

Facility Contacts

Amanda Garrioch

Role: primary

amanda.garrioch@uhn.ca

416-340-4800 ext. 2746

References

Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

Reference Type: BACKGROUND

PMID: 9635069 (View on PubMed)

Godoy LC, Frankfurter C, Cooper M, Lay C, Maunder R, Farkouh ME. Association of Adverse Childhood Experiences With Cardiovascular Disease Later in Life: A Review. JAMA Cardiol. 2021 Feb 1;6(2):228-235. doi: 10.1001/jamacardio.2020.6050.

Reference Type: BACKGROUND

PMID: 33263716 (View on PubMed)

Maunder RG, Hunter JJ, Tannenbaum DW, Le TL, Lay C. Physicians' knowledge and practices regarding screening adult patients for adverse childhood experiences: a survey. BMC Health Serv Res. 2020 Apr 15;20(1):314. doi: 10.1186/s12913-020-05124-6.

Reference Type: BACKGROUND

PMID: 32293444 (View on PubMed)

Maunder RG, Tannenbaum DW, Permaul JA, Nutik M, Haber C, Mitri M, Costantini D, Hunter JJ. The prevalence and clinical correlates of adverse childhood experiences in a cross-sectional study of primary care patients with cardiometabolic disease or risk factors. BMC Cardiovasc Disord. 2019 Dec 19;19(1):304. doi: 10.1186/s12872-019-01277-3.

Reference Type: BACKGROUND

PMID: 31881981 (View on PubMed)

Other Identifiers

19-5967

Identifier Type: -

Identifier Source: org_study_id