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

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05359822
• Collaborator: (none)
• Enrollment: 7,000
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Computed Tomography for Calicum Scoring	Other: Image-Based Report	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 7000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in LDL Cholesterol [baseline-12 months]

   Change in LDL cholesterol levels obtained from EMR between baseline to 12 months

Secondary Outcome Measures

1. Change in Total Cholesterol [baseline-12 months]

   Change in Total Cholesterol

2. Change in Triglycerides [baseline-12 months]

   Change in Triglycerides

3. Change in HDL cholesterol [baseline-12 months]

   Change in HDL cholesterol

4. Change in Weight [baseline-12 months]

   Change in Weight

5. Change in Systolic blood pressure [baseline-12 months]

   Change in Systolic blood pressure

6. Change in Diastolic blood pressure [baseline-12 months]

   Change in Diastolic blood pressure

7. Change in HbA1c [baseline-12 months]

   Change in HbA1c

8. Smoking Cessation Visits as measured by medical record review - yes/no [12 months]

   Smoking Cessation Encounters

9. Statin prescriptions written as measured by medical record review - yes/no [12 months]

   Statin prescriptions

10. Aspirin prescriptions written as measured by medical record review - yes/no [12 months]

    Aspirin prescriptions

11. Stress tests ordered as measured by medical record review - yes/no [12 months]

    Stress testing

Other Outcome Measures

1. Exploratory: Change in Perception of Risk of Heart Diseases as measured by Perception of Heart Disease Risk score [Baseline, 3 months, 12 months]

   Perception of Heart Disease Risk Disease Risk score

2. Exploratory: Change in Motivation to Change Behavior as measured by Motivation to Change Behavior (TSRQ) Survey Behavior [Baseline, 3 months, 12 months]

   Motivation to Change Behavior (TSRQ) Disease Risk score

3. Exploratory: Change in Medication adherence as measured by Medication adherence (MARSS) Survey [Baseline, 3 months, 12 months]

   Changes in medication adherence (MARSS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Sadeer Al-Kindi, MD, University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT05359822
• Other Study ID Numbers: STUDY20210601
• First Posted: May 4, 2022
• Last Update Posted: May 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 4, 2022