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

NCT ID: NCT05359822

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

7000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Cardiac Computed Tomography for Calicum Scoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clinical Standard Report Only

Participants referred for Coronary Artery Calcium Score Test that receive clinical standard CAC risk report only.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Image-Based Report

Intervention Type OTHER

Participants will receive the new coronary artery calcium score risk report plus the old report

Interventions

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Image-Based Report

Participants will receive the new coronary artery calcium score risk report plus the old report

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sanjay Rajagopalan

Assistant Professor of Medicine and Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sadeer Al-Kindi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Central Contacts

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Heidi Osborne

Role: CONTACT

216-844-2833

Other Identifiers

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STUDY20210601

Identifier Type: -

Identifier Source: org_study_id

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