Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot

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.

Conditions

• Adverse Childhood Experiences
• Coronary Artery Disease

Interventions

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.

Sponsors & Collaborators

• Socar Research SA

  collaborator NETWORK

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Michael Farkouh, MD · University Health Network-Toronto General Hospital, Canada

• Claudia Frankfurter, MD · University Health Network-Toronto General Hospital, Canada

• Lucas C Godoy, MD · University Health Network-Toronto General Hospital, Canada

• Christine Lay, MD · Women's College Hospital, Canada

• Robert Maunder, MD · Mount Sinai Hospital, Canada

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2022-12-31

Completion

2023-06-30

Countries

• Canada

Study Locations