Adverse Childhood ExperiencesNCT04752228
Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot
A study testing Philadelphia ACE Survey and Lifestyle Assessment in people with Adverse Childhood Experiences and Coronary Artery Disease, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Childhood Experiences, Coronary Artery Disease
- What is being tested?
- Philadelphia ACE Survey and Lifestyle Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years at screening
- 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.
- Able to complete a survey independently
- Access to a phone
- Willingness to participate as evidenced by signing of the study informed consent form
Who cannot join
- Inability to speak, read and write in English
- Cognitive impairment
- Severe physical or mental illness
- Limited life expectancy (projected to be less than 1 year)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Peter Munk Cardiac Centre - University Health Network
Toronto
Amanda Garrioch, 416-340-4800 ext. 2746, amanda.garrioch@uhn.ca
About this study
Official title: 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.
Read the 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.
- Being tested
- Philadelphia ACE Survey, Lifestyle Assessment
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philadelphia ACE SurveyOther
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 AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ACE Screen | Experimental | 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. Receives: Other: Philadelphia ACE Survey; Other: Lifestyle Assessment |
| Lifestyle Assessment | Other | 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. Receives: Other: Lifestyle Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported quality of life
Degree of change in quality of life measured by the Short Form (36) Health Survey questionnaire
Measured: 3 and 6 months
Secondary outcomes (5)
Mortality
Rate of all-cause mortality
Measured: 6 months
Cardiovascular hospitalization
Rate of hospitalization for ACS, heart failure, stroke and atrial fibrillation
Measured: 6 months
Myocardial infarction
Rate of myocardial infarction
Measured: 6 months
Stroke
Rate of stroke
Measured: 6 months
Need for urgent repeat coronary revascularization
Rate of need for urgent repeat coronary revascularization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Socar Research SA
- Responsible party
- Principal investigator, Michael Farkouh, University Health Network, Toronto
- Investigators
- Michael Farkouh, MD, Principal investigator, University Health Network-Toronto General Hospital, CanadaClaudia Frankfurter, MD, Principal investigator, University Health Network-Toronto General Hospital, CanadaLucas C Godoy, MD, Principal investigator, University Health Network-Toronto General Hospital, CanadaChristine Lay, MD, Principal investigator, Women's College Hospital, CanadaRobert Maunder, MD, Principal investigator, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752228
- Sponsor's protocol ID
- 19-5967
- Status last verified
- May 2022
- First submitted
- 9 Feb 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9635069Godoy 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.
PubMed 33263716Maunder 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.
PubMed 32293444Maunder 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.
PubMed 31881981
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Childhood Experiences in Patients With Coronary Artery Disease: a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04752228
- Acronym / sponsor ID
- 19-5967
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Socar Research SA
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACE Screen | Experimental | Other: Philadelphia ACE Survey, Other: Lifestyle AssessmentAt 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. |
| Lifestyle Assessment | Other | Other: Lifestyle AssessmentAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years at screening
- 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.
- Able to complete a survey independently
- Access to a phone
- Willingness to participate as evidenced by signing of the study informed consent form
Key exclusion criteria (4 listed)
- Inability to speak, read and write in English
- Cognitive impairment
- Severe physical or mental illness
- Limited life expectancy (projected to be less than 1 year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philadelphia ACE SurveyThe 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 | ACE Screen |
| Lifestyle AssessmentThe 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 | ACE Screen, Lifestyle Assessment |
Primary outcome
Patient-reported quality of life
Time frame: 3 and 6 months
Degree of change in quality of life measured by the Short Form (36) Health Survey questionnaire
5 secondary outcomes
Mortality
Time frame: 6 months
Cardiovascular hospitalization
Time frame: 6 months
Myocardial infarction
Time frame: 6 months
Stroke
Time frame: 6 months
Need for urgent repeat coronary revascularization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 9635069Felitti 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.
- Background: PubMed 33263716Godoy 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.
- Background: PubMed 32293444Maunder 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.
- Background: PubMed 31881981Maunder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Farkouh, MD principal investigator
University Health Network-Toronto General Hospital, Canada
Claudia Frankfurter, MD principal investigator
University Health Network-Toronto General Hospital, Canada
Lucas C Godoy, MD principal investigator
University Health Network-Toronto General Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philadelphia ACE Survey and Lifestyle Assessment in people with Adverse Childhood Experiences and Coronary Artery Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Farkouh, MD (416-340-3141, michael.farkouh@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported quality of life (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04752228, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.