Relationship Between High-Density Lipoprotein Subtypes and Coronary Heart Disease Prognosis. (RHDLS-CHD)

December 19, 2023 updated by: Beijing Tsinghua Chang Gung Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua changgung Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of the major adverse cardiovascular event (MACE)
Time Frame: From date of enrollment until the date of first documented progression or date of MACE, whichever came first, assessed up to 3 years.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of the all-cause death
Time Frame: 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
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
Number of the heart failure
Time Frame: From date of enrollment until the date of first documented progression or date of heart failure, whichever came first, assessed up to 3 years
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
In-stent restenosis
Time Frame: 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
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
Number of the target lesion revascularization
Time Frame: 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.
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.
Number of the non-target lesion revascularization
Time Frame: 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.
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.
Number of the major adverse cardiovascular event (MACE)
Time Frame: From date of enrollment until the date of MACE during hospitalization.
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.
Number of the major adverse cardiovascular event (MACE)
Time Frame: rom date of enrollment until the date of first documented progression or date of MACE, whichever came first, assessed up to 1 years.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Collaborators

Guangdong Guosheng Medical Technology

Investigators

  • Study Director: Yu Geng, Beijing Tsinghua Changgeng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-RHDLS-CHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

undecided whether to share

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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