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

NCT06190834 | Recruiting

• 1 other identifier: 2023-RHDLS-CHD
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HDL; Coronary Heart Disease

Keywords

High-Density Lipoprotein; Subtypes; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of the all-cause death

  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

• Number of the heart failure

  From date of enrollment until the date of first documented progression or date of heart failure, whichever came first, assessed up to 3 years

• In-stent restenosis

  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

• Number of 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.

• Number of the non-target lesion revascularization

  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.

Study Arms (1)

The patients with coronary heart disease diagnosed by coronary angiography

The patients with coronary heart disease diagnosed by coronary angiography in the department of cardiology of Beijing Tsinghua Changgeng Hospital. Except patients with severe valvular disease, severe myocarditis, severe hepatic and renal insufficiency, thyroid insufficiency, severe infectious or systemic inflammatory diseases, severe blood diseases, malignant tumors, etc.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The age of the patients is over 18 years old;
• Coronary artery disease was confirmed by coronary angiography.

You may not qualify if:

• Severe valvular disease, severe myocarditis, severe hepatic and renal insufficiency, thyroid insufficiency, severe infectious or systemic inflammatory diseases, severe blood diseases, malignant tumors.
• Lack of data on HDL subtypes.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Guangdong Guosheng Medical Technology: collaborator

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yu Geng

  Beijing Tsinghua Changgeng Hospital

  STUDY DIRECTOR

Central Study Contacts

Yu Geng

CONTACT

010-56119519; gya02137@btch.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 5, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 5, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)