Risk Prediction of Disease Progression in Early-Onset Coronary Atherosclerosis

NCT07316452 | Recruiting

• 1 other identifier: 2024-2502
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Progression of Coronary Plaque on Computed Tomography

  Progression of coronary atherosclerotic plaque assessed by comparing baseline and follow-up coronary computed tomography scans.

  From baseline to follow-up coronary CT, up to 3 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead

Study Sites (1)

FuWai hospital

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Zhihui Hou, MD, PhD

CONTACT

+86 15011451210; konglingyihui@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Department of Radiology

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

CN (1)