Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

Adverse Childhood Experiences in Patients With Coronary Artery Disease: a Pilot Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Adverse Childhood Experiences
• Intervention / Treatment: Other: Philadelphia ACE Survey; Other: Lifestyle Assessment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Farkouh, MD; Phone Number: 416-340-3141; Email: michael.farkouh@uhn.ca
• Study Contact Backup: Name: Amanda Garrioch; Phone Number: 2746 416-340-4800; Email: amanda.garrioch@uhn.ca

Study Locations

• Canada
  • Toronto, Canada
    • Recruiting
    • Peter Munk Cardiac Centre - University Health Network
    • Contact: Amanda Garrioch; Phone Number: 2746 416-340-4800; Email: amanda.garrioch@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported quality of life	Degree of change in quality of life measured by the Short Form (36) Health Survey questionnaire	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of all-cause mortality	6 months
Cardiovascular hospitalization	Rate of hospitalization for ACS, heart failure, stroke and atrial fibrillation	6 months
Myocardial infarction	Rate of myocardial infarction	6 months
Stroke	Rate of stroke	6 months
Need for urgent repeat coronary revascularization	Rate of need for urgent repeat coronary revascularization	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health behaviour	Change in health behaviours, measured using constructs derived from the American Heart Association	3 and 6 months
Depression	Change in severity of depression, measured using the Patient Health Questionnaire 9	3 and 6 months
Anxiety	Change in severity of anxiety, measured using the Generalized Anxiety Disorder-7 scale	3 and 6 months
Angina	Change in angina, measured by the Seattle Angina Questionnaire	3 and 6 months
Perceived need for care	Change in perceived need for care, measured by the Modified Perceived Need for Care Questionnaire	3 and 6 months
Prevalence of ACE	Percentage of patients with CAD who report history of ACE	0 and 6 months
Patient preferences on ACE screening	Scale assessing 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	6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Socar Research SA
• Investigators: Principal Investigator: Michael Farkouh, MD, University Health Network-Toronto General Hospital, Canada; Principal Investigator: Claudia Frankfurter, MD, University Health Network-Toronto General Hospital, Canada; Principal Investigator: Lucas C Godoy, MD, University Health Network-Toronto General Hospital, Canada; Principal Investigator: Christine Lay, MD, Women's College Hospital, Canada; Principal Investigator: Robert Maunder, MD, Mount Sinai Hospital, Canada

Publications and helpful links

General Publications

• 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.
• 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. Review.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 19-5967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No