Evaluation of Valvular Heart Disease Using Cardiac CT

May 11, 2025 updated by: Hideki Koike, Toho University

Evaluation of Valvular Heart Disease: Multicenter Registry of Noninvasive Imaging Modalities by Cardiac CT

The EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis.

  1. Assessing the accuracy of cardiac CT in evaluating cardiac structure, volume, function, and myocardium in VHD patients.
  2. Comparing the severity, classification, and etiology (primary vs. functional) of VHD.
  3. Monitoring serial changes in VHD severity via echocardiography.
  4. Investigating the relationship between echocardiographic and CT-derived parameters.
  5. Examining the correlation between imaging findings, VHD interventions, and patient prognosis.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Tokyo
      • Ota, Tokyo, Japan, 143-8540
        • Recruiting
        • Toho University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted at 7 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.

Description

Inclusion Criteria:

  • Patients with at least moderate valvular heart disease who had a cardiac CT with 64 or more rows
  • 18 years of age or older

Exclusion Criteria:

  • Less than 18 years old
  • Acute VHD
  • Infectious endocarditis
  • Patients with post-VHD intervention
  • Poor CT image quality for analyzing CT data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the 1-year composite endpoint of all-cause death and major cardiac adverse events (MACE) including VHD intervention.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toho University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 11, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A24904

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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