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Not yet recruiting NCT05359822

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

No phase Interventional Cardiac Computed Tomography for Calicum Scoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Image-Based Report.
Who it may be relevant to
Registry conditions: Cardiac Computed Tomography for Calicum Scoring. Basic parameters: 40 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigating the Impact of a Patient-directed Coronary Artery Calcium Score Report: A Randomized-controlled Trial

Overview

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).

Interventions

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

Primary outcome measures

  • Change in LDL Cholesterol [Time frame: baseline-12 months]
Secondary outcome measures (11)
  • 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]
  • Change in Systolic blood pressure [Time frame: baseline-12 months]
  • Change in Diastolic blood pressure [Time frame: baseline-12 months]
  • Change in HbA1c [Time frame: baseline-12 months]
  • Smoking Cessation Visits as measured by medical record review - yes/no [Time frame: 12 months]
  • Statin prescriptions written as measured by medical record review - yes/no [Time frame: 12 months]
  • Aspirin prescriptions written as measured by medical record review - yes/no [Time frame: 12 months]
  • Stress tests ordered as measured by medical record review - yes/no [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05359822 · STUDY20210601

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗