Outcomes for people hospitalized with coronary artery disease
Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study
This project will see how diagnostic tests and real-world treatment choices relate to outcomes for adults hospitalized with confirmed or suspected coronary heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shenyang Northern Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06216847 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center cohort enrolling adults hospitalized with confirmed or suspected coronary heart disease to build a comprehensive clinical and imaging dataset. Participants will undergo at least one coronary imaging test (CTA, IVUS, or OCT) and one functional assessment (FFR, CT-FFR, or QFR), with treatments and outcomes recorded over time. The investigators will combine lesion-level imaging, lab and clinical data to explore inflammation-related risk, lesion-based risk stratification, and real-world antithrombotic strategies. Big-data mining methods will be used to derive risk models and optimize clinical decision pathways.
Who should consider this trial
Good fit: Adults (age 18+) hospitalized with confirmed or suspected coronary heart disease who can provide consent and who undergo at least one coronary imaging and one functional test are ideal candidates.
Not a fit: People who cannot complete required imaging or functional testing, who have very limited life expectancy, or who cannot participate in follow-up are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, the findings could help doctors personalize diagnosis and treatment plans to reduce heart attacks and other bad outcomes in people with coronary disease.
How similar studies have performed: Large registries and cohort studies have yielded valuable real-world insights for coronary disease, but combining detailed lesion imaging, functional testing, and big-data analytics in a single 'holographic' dataset is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Hospitalization due to either confirmed or suspected CHD combined with one of the following features: previous PCI or CABG; previous myocardial infarction; previous coronary angiography revealing ≥ 50% stenosis in major coronary vessels; presentation with chest pain and pre-test probability of CHD \> 65%; laboratory tests revealing objective evidence of myocardial ischemia; coronary CT angiography (CTA) showed ≥ 30% stenosis in major coronary vessels * Subjects undergoing at least one coronary imaging and one functional examination. Imaging examinations include coronary CTA, intravascular ultrasound (IVUS), or optical coherence tomography (OCT). Functional examination include fraction flow reservation (FFR), CT-FFR or quantitative flow ratio (QFR). * Written informed consent provided. Exclusion Criteria: * History of mental illness, drug or alcohol abuse, or being unable to cooperate with follow-up visits for any reason; * Life expectancy \<1 year * Pregnant or plan to be pregnant within 1 year * Subjects participating in any other clinical trial * Other conditions deemed unsuitable for inclusion by the investigator
Where this trial is running
Shenyang, Liaoning
- General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Yaling Han, MD — The General Hospital of Northern Theater Command
- Study coordinator: Yi Li, MD
- Email: doctorliyi@126.com
- Phone: +86-24-28897309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.