NCT06937125

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Mar 2025Mar 2028

Study Start

First participant enrolled

March 12, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

April 18, 2025

Last Update Submit

May 11, 2025

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

  • the 1-year composite endpoint of all-cause death and major cardiac adverse events (MACE) including VHD intervention.

    one year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toho University

Ōta-ku, Tokyo, 143-8540, Japan

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Hideki Koike, MD, PhD

CONTACT

81+3-3762-4151hideki.koike@med.toho-u.ac.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2025

First Posted

April 22, 2025

Study Start

March 12, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations

JP(1)