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

Not Applicable

Not yet recruiting

• Conditions: Cardiac Computed Tomography for Calicum Scoring
• Interventions: Other: Image-Based Report

• Registration Number: NCT05359822
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-04
• Status Verified: 2024-06
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Study Start: 2025-07-01
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical Standard Report plus Image-Based Report	Image-Based Report	Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report plus additional image-based report.

Primary Outcome Measures

Name	Time	Method
Change in LDL Cholesterol	baseline-12 months	Change in LDL cholesterol levels obtained from EMR between baseline to 12 months

Secondary Outcome Measures

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