Evaluation of Valvular Heart Disease Using Cardiac CT

NCT ID: NCT06937125

Last Updated: 2025-05-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-12

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Valvular Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Toho University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hideki Koike

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toho University

Ōta-ku, Tokyo, Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hideki Koike, MD, PhD

Role: CONTACT

81+3-3762-4151

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ethics Committee of the Toho University

Role: primary

81+3-5763-6534

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A24904

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.