Coronary DiseaseNCT07316452
Risk Prediction of Disease Progression in Early-Onset Coronary Atherosclerosis
An observational study of Coronary Disease and Young Adult, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial summary
This study is part of a nationwide research project in China that aims to better understand how coronary artery disease develops and progresses in young adults. The study will enroll approximately 10,000 participants aged 45 years or younger who undergo coronary CT scans at multiple hospitals across China. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Coronary Disease, Young Adult
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2028
- How long will I take part?
- 3 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population includes adults aged 18 to 45 years with symptoms suggestive of coronary artery disease who undergo coronary computed tomography (CT) in participating centers across China. Participants are prospectively and consecutively enrolled into a nationwide observational registry after providing written informed consent and are followed longitudinally for disease progression.
Who may be able to join
- Age between 18 and 45 years at the time of enrollment.
- Presence of symptoms suggestive of coronary artery disease and completion of coronary computed tomography (CT) examination.
- Ability and willingness to provide written informed consent and to participate in follow-up assessments.
Who cannot join
- Inability or unwillingness to complete follow-up assessments.
- Inability to provide written informed consent.
- History of coronary revascularization, including percutaneous coronary intervention or coronary artery bypass grafting.
- Poor-quality coronary computed tomography images that are inadequate for reliable plaque assessment.
- Presence of severe systemic disease with limited life expectancy that may interfere with study follow-up.
- Pregnant or breastfeeding women.
- Participation in another clinical study that may interfere with the outcomes of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
FuWai hospital
Beijing, 100000
Zhihui Hou, MD，PhD, +86 15011451210, konglingyihui@126.com
About this study
This study is part of a nationwide research project in China that aims to better understand how coronary artery disease develops and progresses in young adults. The study will enroll approximately 10,000 participants aged 45 years or younger who undergo coronary CT scans at multiple hospitals across China.
Information collected at enrollment includes basic health information, cardiovascular risk factors, blood test results, medication use, lifestyle habits, and, for some participants, genetic data. Participants will undergo follow-up coronary CT scans after several years to evaluate changes in coronary artery plaque and disease progression.
By analyzing these clinical and imaging data, the study aims to identify factors associated with disease progression and to develop prediction models that may help estimate an individual's future risk of coronary plaque progression and cardiovascular events. The results of this study may contribute to improved risk assessment and early prevention strategies for coronary artery disease in young populations.
- Conditions
- Coronary Disease, Young Adult
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Coronary Plaque on Computed Tomography
Progression of coronary atherosclerotic plaque assessed by comparing baseline and follow-up coronary computed tomography scans.
Measured: From baseline to follow-up coronary CT, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- 10,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihui Hou, Fu Wai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316452
- Sponsor's protocol ID
- 2024-2502
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Prediction of Disease Progression in Early-Onset Coronary Atherosclerosis
- ClinicalTrials.gov ID
- NCT07316452
- Acronym / sponsor ID
- 2024-2502
- Conditions
- Coronary Disease, Young Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 5 Jan 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.
This study is part of a nationwide research project in China that aims to better understand how coronary artery disease develops and progresses in young adults. The study will enroll approximately 10,000 participants aged 45 years or younger who undergo coronary CT scans at multiple hospitals across China.
Information collected at enrollment includes basic health information, cardiovascular risk factors, blood test results, medication use, lifestyle habits, and, for some participants, genetic data. Participants will undergo follow-up coronary CT scans after several years to evaluate changes in coronary artery plaque and disease progression.
By analyzing these clinical and imaging data, the study aims to identify factors associated with disease progression and to develop prediction models that may help estimate an individual's future risk of coronary plaque progression and cardiovascular events. The results of this study may contribute to improved risk assessment and early prevention strategies for coronary artery disease in young populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes adults aged 18 to 45 years with symptoms suggestive of coronary artery disease who undergo coronary computed tomography (CT) in participating centers across China. Participants are prospectively and consecutively enrolled into a nationwide observational registry after providing written informed consent and are followed longitudinally for disease progression.
Key inclusion criteria (3 listed)
- Age between 18 and 45 years at the time of enrollment.
- Presence of symptoms suggestive of coronary artery disease and completion of coronary computed tomography (CT) examination.
- Ability and willingness to provide written informed consent and to participate in follow-up assessments.
Key exclusion criteria (7 listed)
- Inability or unwillingness to complete follow-up assessments.
- Inability to provide written informed consent.
- History of coronary revascularization, including percutaneous coronary intervention or coronary artery bypass grafting.
- Poor-quality coronary computed tomography images that are inadequate for reliable plaque assessment.
- Presence of severe systemic disease with limited life expectancy that may interfere with study follow-up.
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
Progression of Coronary Plaque on Computed Tomography
Time frame: From baseline to follow-up coronary CT, up to 3 years
Progression of coronary atherosclerotic plaque assessed by comparing baseline and follow-up coronary computed tomography scans.
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 5 Jan 2026.
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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 Coronary Disease and Young Adult, run by Fu Wai Hospital, Beijing, China at 1 site in China.
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 7 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 5 Jan 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 China. 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 Zhihui Hou, MD, PhD (+86 15011451210, konglingyihui@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Coronary Plaque on Computed Tomography (time frame: From baseline to follow-up coronary CT, up to 3 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 5 Jan 2026.