Image-Based Report
OtherParticipants will receive the new coronary artery calcium score risk report plus the old report
Not Yet Recruiting
NCT Number: NCT05359822
Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report
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).
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
40 year–89 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Change in LDL Cholesterol
Time frame: baseline-12 months
Change in LDL cholesterol levels obtained from EMR between baseline to 12 months
Secondary outcomes
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Change in Total Cholesterol
Time frame: baseline-12 months
Change in Total Cholesterol
-
Change in Triglycerides
Time frame: baseline-12 months
Change in Triglycerides
-
Change in HDL cholesterol
Time frame: baseline-12 months
Change in HDL cholesterol
-
Change in Weight
Time frame: baseline-12 months
Change in Weight
-
Change in Systolic blood pressure
Time frame: baseline-12 months
Change in Systolic blood pressure
-
Change in Diastolic blood pressure
Time frame: baseline-12 months
Change in Diastolic blood pressure
-
Change in HbA1c
Time frame: baseline-12 months
Change in HbA1c
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Smoking Cessation Visits as measured by medical record review - yes/no
Time frame: 12 months
Smoking Cessation Encounters
-
Statin prescriptions written as measured by medical record review - yes/no
Time frame: 12 months
Statin prescriptions
-
Aspirin prescriptions written as measured by medical record review - yes/no
Time frame: 12 months
Aspirin prescriptions
-
Stress tests ordered as measured by medical record review - yes/no
Time frame: 12 months
Stress testing
Other outcomes
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Exploratory: Change in Perception of Risk of Heart Diseases as measured by Perception of Heart Disease Risk score
Time frame: Baseline, 3 months, 12 months
Perception of Heart Disease Risk Disease Risk score
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Exploratory: Change in Motivation to Change Behavior as measured by Motivation to Change Behavior (TSRQ) Survey Behavior
Time frame: Baseline, 3 months, 12 months
Motivation to Change Behavior (TSRQ) Disease Risk score
-
Exploratory: Change in Medication adherence as measured by Medication adherence (MARSS) Survey
Time frame: Baseline, 3 months, 12 months
Changes in medication adherence (MARSS)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospitals Cleveland Medical Center
Other
Registry information
Official study title
Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 4, 2022
- Registry last updated
- Aug 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.