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Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04752228
Enrollment
100
Registered
2021-02-12
Start date
2021-09-01
Completion date
2023-06-30
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences, Coronary Artery Disease

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.

Interventions

OTHERPhiladelphia 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.

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.

Sponsors

Socar Research SA
CollaboratorNETWORK
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Patient-reported quality of life3 and 6 monthsDegree of change in quality of life measured by the Short Form (36) Health Survey questionnaire

Secondary

MeasureTime frameDescription
Mortality6 monthsRate of all-cause mortality
Cardiovascular hospitalization6 monthsRate of hospitalization for ACS, heart failure, stroke and atrial fibrillation
Myocardial infarction6 monthsRate of myocardial infarction
Stroke6 monthsRate of stroke
Need for urgent repeat coronary revascularization6 monthsRate of need for urgent repeat coronary revascularization

Other

MeasureTime frameDescription
Health behaviour3 and 6 monthsChange in health behaviours, measured using constructs derived from the American Heart Association
Patient preferences on ACE screening6 monthsScale 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
Depression3 and 6 monthsChange in severity of depression, measured using the Patient Health Questionnaire 9
Anxiety3 and 6 monthsChange in severity of anxiety, measured using the Generalized Anxiety Disorder-7 scale
Angina3 and 6 monthsChange in angina, measured by the Seattle Angina Questionnaire
Perceived need for care3 and 6 monthsChange in perceived need for care, measured by the Modified Perceived Need for Care Questionnaire
Prevalence of ACE0 and 6 monthsPercentage of patients with CAD who report history of ACE

Countries

Canada

Contacts

Primary ContactMichael Farkouh, MD
michael.farkouh@uhn.ca416-340-3141
Backup ContactAmanda Garrioch
amanda.garrioch@uhn.ca416-340-4800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026