Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752228
• Other study ID #: 19-5967
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: Michael Farkouh, MD
• Phone: 416-340-3141
• Email: michael.farkouh[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Peter Munk Cardiac Centre - University Health Network	Toronto

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Socar Research SA

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health behaviour	Change in health behaviours, measured using constructs derived from the American Heart Association	3 and 6 months
Other	Depression	Change in severity of depression, measured using the Patient Health Questionnaire 9	3 and 6 months
Other	Anxiety	Change in severity of anxiety, measured using the Generalized Anxiety Disorder-7 scale	3 and 6 months
Other	Angina	Change in angina, measured by the Seattle Angina Questionnaire	3 and 6 months
Other	Perceived need for care	Change in perceived need for care, measured by the Modified Perceived Need for Care Questionnaire	3 and 6 months
Other	Prevalence of ACE	Percentage of patients with CAD who report history of ACE	0 and 6 months
Other	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
Primary	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	Mortality	Rate of all-cause mortality	6 months
Secondary	Cardiovascular hospitalization	Rate of hospitalization for ACS, heart failure, stroke and atrial fibrillation	6 months
Secondary	Myocardial infarction	Rate of myocardial infarction	6 months
Secondary	Stroke	Rate of stroke	6 months
Secondary	Need for urgent repeat coronary revascularization	Rate of need for urgent repeat coronary revascularization	6 months