Relationship Between High-Density Lipoprotein Subtypes and Coronary Heart Disease Prognosis.

Coronary Heart Disease Clinical Trial

— RHDLS-CHD  

Official title:

Relationship Between High Density Lipoprotein Subtypes and Prognosis in Coronary Heart Disease Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190834
• Other study ID #: 2023-RHDLS-CHD
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: September 2023
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Yu Geng
• Phone: 010-56119519
• Email: gya02137[@]btch.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• HDL
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital	Guangdong Guosheng Medical Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the major adverse cardiovascular event (MACE)	MACE includes cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and planned coronary reconstruction therapy.; Cardiovascular Death: Death due to cardiac causes, such as myocardial infarction, heart failure, arrhythmia, etc. Non-Fatal Myocardial Infarction: If a patient survives this condition, it is called a nonfatal myocardial infarction. Non-Fatal Stroke: A stroke is a neurological disorder caused by disruption of the blood supply to the brain. A non-fatal stroke means that the patient has experienced a stroke but survived. Unplanned Coronary Revascularization: This event refers to the unplanned reconstruction of the coronary arteries, which may involve either interventional therapy (such as coronary angioplasty) or surgical procedures (such as coronary artery bypass surgery).	From date of enrollment until the date of first documented progression or date of MACE, whichever came first, assessed up to 3 years.
Secondary	Number of the all-cause death	Deaths from all causes occurred between definitive diagnosis and the end of follow-up.	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
Secondary	Number of the heart failure	For patients who already have organic heart disease can not engage in any physical work, even in the state of rest, there are heart failure symptoms, which are significantly worse after a little activity.	From date of enrollment until the date of first documented progression or date of heart failure, whichever came first, assessed up to 3 years
Secondary	In-stent restenosis	In-stent restenosis is defined as an angiogram diameter stenosis of 50% or more in one segment of the stent or 5mm segment adjacent to the stent.	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
Secondary	Number of the target lesion revascularization	Target lesions include the 5mm range within the stent as well as the proximal and distal end of the stent. Repeated interventional therapy or bypass surgery for this segment is the target lesion revascularization.	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.
Secondary	Number of the non-target lesion revascularization	Non-target lesion revascularization, including PCI or CABG, due to progression of the original lesion or newly formed lesions in areas other than the target lesion.	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.
Secondary	Number of the major adverse cardiovascular event (MACE)	MACE includes cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and planned coronary reconstruction therapy.	From date of enrollment until the date of MACE during hospitalization.
Secondary	Number of the major adverse cardiovascular event (MACE)	MACE includes cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and planned coronary reconstruction therapy.	rom date of enrollment until the date of first documented progression or date of MACE, whichever came first, assessed up to 1 years.