NCT06190834 Relationship Between High-Density Lipoprotein Subtypes and Coronary Heart Disease Prognosis.
| NCT ID | NCT06190834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tsinghua Chang Gung Hospital |
| Condition | HDL |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2023-12-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cardiovascular disease (CVD) is the leading cause of human mortality worldwide, imposing substantial societal and economic burdens. Traditionally, high-density lipoprotein (HDL) has been branded as the "beneficial" lipoprotein. The Framingham study found that for every 1mg/dl increase in HDL, the risk of coronary heart disease (CHD) was reduced by 2% in men and 3% in women. Subsequent studies further affirmed the inverse correlation between HDL and the risk of CHD. However, these findings were first challenged by Mendelian randomization studies which failed to identify a causal relationship between HDL and CHD. Moreover, randomized controlled trials demonstrated that therapeutically increasing plasma HDL concentrations did not reduce the risk of CHD events, prompting doubts about HDL's status as "good cholesterol." The relationship between HDL and CHD might be more intricate than previously believed, possibly not just mediated by the quantity of HDL but also intimately linked with its function. Several cross-sectional studies have confirmed the relationship between HDL subtypes and the severity of disease in CHD patients, yet findings are inconsistent. Conventional testing methods lack a universally accepted standard for defining or describing HDL subfractions, with issues like expensive equipment, poor repeatability, cumbersome operation, slow analysis, and low throughput. Microfluidic electrophoresis technology combines the merits of electrophoresis with microfluidic chip technology. This method facilitates efficient separation of substances in microchannels on a substrate, providing rapid and consistent results. Utilizing the latest microfluidic chip technology for HDL subfraction detection offers quick, accurate, and straightforward analysis with minimal sample volume and automation. It precisely reflects the serum concentrations of HDL subfractions HDL2b and HDL3, addressing the current pitfalls of clinical HDL subfraction analysis methods. This approach is poised to become the standard method for HDL subfraction testing. In conclusion, existing studies on the association between HDL subtypes and CHD remain inconsistent, with most having a small sample size. Our study, leveraging microfluidic chip technology for HDL subfraction detection, aims to further investigate: the prognostic value of HDL subtypes for the long-term outcomes of CHD patients, building a risk prediction model for adverse cardiovascular events that includes HDL subtypes.
Eligibility Criteria
Inclusion Criteria: 1. The age of the patients is over 18 years old; 2. Coronary artery disease was confirmed by coronary angiography. Exclusion Criteria: 1. Severe valvular disease, severe myocarditis, severe hepatic and renal insufficiency, thyroid insufficiency, severe infectious or systemic inflammatory diseases, severe blood diseases, malignant tumors. 2. Lack of data on HDL subtypes.
Contact & Investigator
Yu Geng
STUDY DIRECTOR
Beijing Tsinghua Changgeng Hospital
Frequently Asked Questions
Who can join the NCT06190834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HDL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06190834 currently recruiting?
Yes, NCT06190834 is actively recruiting participants. Contact the research team at gya02137@btch.edu.cn for enrollment information.
Where is the NCT06190834 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06190834 clinical trial?
NCT06190834 is sponsored by Beijing Tsinghua Chang Gung Hospital. The principal investigator is Yu Geng at Beijing Tsinghua Changgeng Hospital. The trial plans to enroll 5,000 participants.