Clinical trial NCT04752228: Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot
Official title: Adverse Childhood Experiences in Patients With Coronary Artery Disease: a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Childhood Experiences
Coronary Artery Disease
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Socar Research SA
First posted: 2021-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: Patient-reported quality of life
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Cardiovascular hospitalization
timeFrame: 6 months
measure: Myocardial infarction
timeFrame: 6 months
measure: Stroke
timeFrame: 6 months
measure: Need for urgent repeat coronary revascularization
timeFrame: 6 months
Other outcomes:
measure: Health behaviour
timeFrame: 3 and 6 months
measure: Depression
timeFrame: 3 and 6 months
measure: Anxiety
timeFrame: 3 and 6 months
measure: Angina
timeFrame: 3 and 6 months
measure: Perceived need for care
timeFrame: 3 and 6 months
measure: Prevalence of ACE
timeFrame: 0 and 6 months
measure: Patient preferences on ACE screening
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Peter Munk Cardiac Centre - University Health Network
Study officials:
affiliation: University Health Network-Toronto General Hospital, Canada
name: Michael Farkouh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network-Toronto General Hospital, Canada
name: Claudia Frankfurter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network-Toronto General Hospital, Canada
name: Lucas C Godoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital, Canada
name: Christine Lay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Hospital, Canada
name: Robert Maunder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.