Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report

Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial

The goal of this study is to examine if communication of image-based cardiovascular risk to patients undergoing coronary artery calcium scoring (CAC) improves patient understanding of their risk for cardiovascular disease when compared with usual care (physician-only report).

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Computed Tomography for Calicum Scoring
• Intervention / Treatment: Other: Image-Based Report

• Study Type: Interventional
• Enrollment (Estimated): 7000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Osborne; Phone Number: 216-844-2833; Email: heidi.osborne@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range: from 40 to 89
• Referred for CAC at UHHS

Exclusion Criteria:

• Less than 40 years of age or over 89 years old.
• Underwent CAC at other locations besides UHHS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Clinical Standard Report Only; Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report only.
Experimental: Clinical Standard Report plus Image-Based Report; Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report plus additional image-based report.	Other: Image-Based Report; Participants will receive the new coronary artery calcium score risk report plus the old report

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL Cholesterol	Change in LDL cholesterol levels obtained from EMR between baseline to 12 months	baseline-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Cholesterol	Change in Total Cholesterol	baseline-12 months
Change in Triglycerides	Change in Triglycerides	baseline-12 months
Change in HDL cholesterol	Change in HDL cholesterol	baseline-12 months
Change in Weight	Change in Weight	baseline-12 months
Change in Systolic blood pressure	Change in Systolic blood pressure	baseline-12 months
Change in Diastolic blood pressure	Change in Diastolic blood pressure	baseline-12 months
Change in HbA1c	Change in HbA1c	baseline-12 months
Smoking Cessation Visits as measured by medical record review - yes/no	Smoking Cessation Encounters	12 months
Statin prescriptions written as measured by medical record review - yes/no	Statin prescriptions	12 months
Aspirin prescriptions written as measured by medical record review - yes/no	Aspirin prescriptions	12 months
Stress tests ordered as measured by medical record review - yes/no	Stress testing	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Change in Perception of Risk of Heart Diseases as measured by Perception of Heart Disease Risk score	Perception of Heart Disease Risk Disease Risk score	Baseline, 3 months, 12 months
Exploratory: Change in Motivation to Change Behavior as measured by Motivation to Change Behavior (TSRQ) Survey Behavior	Motivation to Change Behavior (TSRQ) Disease Risk score	Baseline, 3 months, 12 months
Exploratory: Change in Medication adherence as measured by Medication adherence (MARSS) Survey	Changes in medication adherence (MARSS)	Baseline, 3 months, 12 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Sadeer Al-Kindi, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY20210601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No