Cardiovascular Disease4D-MRINCT07678606
Association Between 4D MRI Parameters and the Clinical Characteristics and Prognosis of Major Chronic Diseases
An observational study of Cardiovascular Disease and Cardiac Magnetic Resonance Imaging, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Cardiac Magnetic Resonance Imaging, Neoplasm
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to 28 Feb 2046
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital
Ulsan, Ulsan, 44033
Mi-Hee Jang MD, 82-52-250-7000, jmh911213@daum.net
About this study
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.
Read the 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.
- Keywords
- Cardiovascular disease, Malignancy, Cardiac Magnetic Resonance Imaging, Hemodynamic parameters
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardiovascular Events (MACE)
Incidence of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure during the follow-up period
Measured: up to 10 years
Secondary outcomes (2)
Peak Wall Shear Stress
peak wall shear stress measured in the ascending aorta using 4D flow MRI
Measured: Perioperative/Periprocedural
Blood Flow Eccentricity
Blood Flow Eccentricity assessed in the ascending aorta using 4D flow MRI
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026
- Primary completion29 Feb 2036 (estimated)
- Study completion28 Feb 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gyung-Min Park, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678606
- Sponsor's protocol ID
- UUH-4DFLOW-2026
- Acronym
- 4D-MRI
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between 4D MRI Parameters and the Clinical Characteristics and Prognosis of Major Chronic Diseases
- ClinicalTrials.gov ID
- NCT07678606
- Acronym / sponsor ID
- 4D-MRI / UUH-4DFLOW-2026
- Keywords
- Cardiovascular disease, Malignancy, Cardiac Magnetic Resonance Imaging, Hemodynamic parameters
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 29 Feb 2036 (estimated)
- Study completion
- 28 Feb 2046 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: up to 10 years
Incidence of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure during the follow-up period
2 secondary outcomes
Peak Wall Shear Stress
Time frame: Perioperative/Periprocedural
Blood Flow Eccentricity
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Cardiac Magnetic Resonance Imaging, run by Ulsan University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gyung-Min Park MD, PhD (82-52-250-8993, gmpark@uuh.ulsan.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.