Association Between 4D MRI Parameters and the Clinical Characteristics and Prognosis of Major Chronic Diseases (4D-MRI)

June 24, 2026 updated by: Gyung-Min Park, Ulsan University Hospital
Cancer and cardiovascular diseases are among the leading causes of morbidity and mortality worldwide. Advanced imaging techniques such as 4D magnetic resonance imaging (MRI) enable quantitative assessment of hemodynamic and functional parameters beyond conventional imaging. The aim of this study is to evaluate the association between 4D MRI derived parameters and the occurrence, severity, and prognosis of major chronic diseases, and to explore their potential role as imaging biomarkers.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a single-center, prospective, observational registry study conducted at Ulsan University Hospital. The study will enroll 1,000 adult patients (≥ 19 years) undergoing cardiac MRI as part of routine clinical care in Korea.

Participants will undergo an additional 4D MRI sequence during the same imaging session, which does not affect clinical decision-making or patient management.

The primary objective of this study is to evaluate the association between quantitative imaging parameters derived from 4D MRI and the occurrence, severity, and prognosis of major chronic diseases.

Study Type

Observational

Enrollment (Estimated)

1000

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

  • South Korea
    • Ulsan
      • Ulsan, Ulsan, South Korea, 44033
        • Ulsan University Hospital
        • 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

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 19 years and older undergoing clinically indicated cardiac MRI at Ulsan University Hospital (Ulsan, South Korea) will be included in the study population. Individuals who provide written informed consent and undergo an additional 4D MRI sequence during the same imaging session will be enrolled in this prospective observational registry.

Description

Inclusion Criteria:

  • Adults aged 19 years and older undergoing clinically indicated Cardiac MRI at Ulsan University Hospital
  • Participants who undergo an additional 4D MRI sequence during the same imaging session
  • Participants who are able to understand the study and provide written informed consent

Exclusion Criteria:

  • Individuals aged < 19 years
  • Individuals with cognitive impairment or communication difficulties unable to provide informed consent
  • Poor-quality MRI images that are not suitable for analysis
  • Individuals deemed inappropriate for study participation by the investigator

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

Cohorts and Interventions

Group / Cohort
Ulsan University Hospital, 4D MRI cohort
Adult patients aged 19 years and older undergoing clinically indicated Cardiac MRI at Ulsan University Hospital who provide written informed consent and undergo an additional 4D MRI sequence during the same imaging session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between 4D flow MRI-derived hemodynamic parameters and disease-specific clinical outcomes
Time Frame: up to 10 years
The association between quantitative hemodynamic parameters derived from 4D flow MRI and pre-specified disease-specific clinical outcomes will be evaluated during follow-up.
up to 10 years

Collaborators and Investigators

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

Sponsor

Ulsan University Hospital

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 (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 29, 2036

Study Completion (Estimated)

February 28, 2046

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UUH-4DFLOW-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is currently undecided whether individual participant data will be shared. Any future data sharing will be subject to institutional policies, ethical considerations, and applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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