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

ConditionCardiac Computed Tomography for Calicum Scoring

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-89

SponsorUniversity Hospitals Cleveland Medical Center

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: from 40 to 89

Referred for CAC at UHHS

Disqualifiers

Less than 40 years of age or over 89 years old.

Underwent CAC at other locations besides UHHS.

Trial design

Design model

Parallel

Treatments tested in this trial

Image-Based Report
Other intervention
Participants will receive the new coronary artery calcium score risk report plus the old report

Treatment groups

7,000 Participants

are divided into 2 treatment groups

Group A: Clinical Standard Report OnlyNo intervention 0 interventions

Group B: Clinical Standard Report plus Image-Based ReportExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in LDL Cholesterol

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

Time frame

baseline-12 months

Secondary outcomes

Change in Total Cholesterol

Time frame

baseline-12 months

Change in Triglycerides

Time frame

baseline-12 months

Change in HDL cholesterol

Time frame

baseline-12 months

Change in Weight

Time frame

baseline-12 months

Other outcomes

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

Time frame

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

Time frame

Baseline, 3 months, 12 months

Exploratory: Change in Medication adherence as measured by Medication adherence (MARSS) Survey

Changes in medication adherence (MARSS)

Time frame

Baseline, 3 months, 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: