Clinical trial NCT06190834: Relationship Between High-Density Lipoprotein Subtypes and Coronary Heart Disease Prognosis.
Official title: Relationship Between High Density Lipoprotein Subtypes and Prognosis in Coronary Heart Disease Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HDL
Coronary Heart Disease
Keywords: High-Density Lipoprotein
Subtypes
Coronary Heart Disease
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Guangdong Guosheng Medical Technology
First posted: 2024-01-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with coronary heart disease diagnosed by coronary angiography in the department of cardiology of Beijing Tsinghua Changgeng Hospital.

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.

Primary outcomes:
measure: Number of the major adverse cardiovascular event (MACE)
timeFrame: From date of enrollment until the date of first documented progression or date of MACE, whichever came first, assessed up to 3 years.
Secondary outcomes:
measure: Number of the all-cause death
timeFrame: From date of enrollment until the date of first documented progression or date of all-cause death, whichever came first, assessed up to 3 years
measure: Number of the heart failure
timeFrame: From date of enrollment until the date of first documented progression or date of heart failure, whichever came first, assessed up to 3 years
measure: In-stent restenosis
timeFrame: From date of enrollment until the date of first documented progression or date of in-stent restenosis, whichever came first, assessed up to 1 years
measure: Number of the target lesion revascularization
timeFrame: From date of enrollment until the date of first documented progression or date of the target lesion revascularization, whichever came first, assessed up to 1 years.
measure: Number of the non-target lesion revascularization
timeFrame: From date of enrollment until the date of first documented progression or date of the non-target lesion revascularization, whichever came first, assessed up to 1 years.
measure: Number of the major adverse cardiovascular event (MACE)
timeFrame: From date of enrollment until the date of MACE during hospitalization.
measure: Number of the major adverse cardiovascular event (MACE)
timeFrame: rom date of enrollment until the date of first documented progression or date of MACE, whichever came first, assessed up to 1 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Yu Geng
role: STUDY_DIRECTOR
References: