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Study on Diagnostic Markers of Stable Coronary Heart Disease with Phlegm-Stasis Syndromes

Study on the Relationship between Coronary Heart Disease with Phlegm-Stasis Syndromes and Low Density Lipoprotein, High Density Lipoprotein Subtypes and Modification Patterns

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079963
Enrollment
Unknown
Registered
2024-01-17
Start date
2021-09-15
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary heart disease

Interventions

Stable coronary heart disease group
:None
Healthy control group:None

Sponsors

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for stable coronary heart disease group: (1) Age 35-85 years old. (2) Diagnostic criteria for CHD: if confirmed by coronary angiography with at least one coronary artery stenosis = 50%, or confirmed by coronary CTA, or with a previous history of old myocardial infarction. (3) Stable CHD (asymptomatic, stable angina pectoris, or acute coronary syndrome with stable condition for more than a month), and the patient is mentally normal with no difficulty in communication and dialogue. (4) Sign an informed consent form and voluntarily participate in this study before being included. Inclusion criteria for the healthy control group: (1) Age range from 35 to 85 years old; (2) The healthy control group defined by the project group (only subjects with overweight or obesity, hypertension, diabetes, hyperuricemia, 1-2 items, and those who do not meet the diagnostic criteria for hyperlipidemia and coronary heart disease); (3) Voluntarily sign a consent form and agree to participate in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria for stable coronary heart disease group: (1) Severe liver and kidney dysfunction. (2) Subjects with infection, fever, trauma, burn, surgery history or active tuberculosis or rheumatic immune disease in the last week. (3) Severe arrhythmia with hemodynamic changes. (4) Chronic heart failure stage C (stage C refers to clinical heart failure stage, where the subject has a basic structural heart disease and has symptoms or signs of heart failure such as shortness of breath, fatigue, and decreased exercise tolerance in the past or present). (5) Merge acute and subacute cerebrovascular diseases. (6) Cardiac valve disease (moderate lesions in one or more valves) or primary cardiomyopathy. (7) Acute exacerbation of chronic obstructive pulmonary disease or pulmonary heart disease or respiratory failure. (8) Severe primary diseases such as combined hematopoietic system or malignant tumors. (9) Organ transplant recipients, pregnant women, or lactating women. Exclusion criteria for healthy control group: (1) Subjects with infection, fever, trauma, burn, surgery history or active tuberculosis or rheumatic immune disease in the last week; (2) Patients with hyperlipidemia and coronary heart disease; (3) Severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.) with hemodynamic changes; (4) Chronic heart failure stage C subjects (stage C refers to clinical heart failure stage, where the subjects have underlying structural heart disease and have symptoms or signs of heart failure such as shortness of breath, fatigue, and decreased exercise tolerance in the past or present); (5) Subjects with combined acute and subacute cerebrovascular diseases; (6) Cardiac valve disease (moderate lesions in one or more valves) or primary cardiomyopathy; (7) Subjects with acute exacerbation of chronic obstructive pulmonary disease or pulmonary heart disease or respiratory failure; (8) Severe primary diseases such as respiratory, hematological, or malignant tumors, or known renal insufficiency [serum creatinine (Cr)>221umol/L in males,>177umol/L in females]; (9) Active liver disease, or accompanied by continuous elevation of serum transaminases for unknown reasons, or detection values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in any one of them>2 times the upper limit of normal reference values; (10) Pregnant and lactating women; (11) Organ transplant subjects; (12) Subjects with severe mental disorders (perception disorders, thinking disorders); (13) Other situations that the research physician deems unsuitable for participation in this trial, including but not limited to: inability of the subjects to follow the study protocol, potential safety hazards to the subjects, etc.

Design outcomes

Primary

MeasureTime frame
total cholesterol;triglycerides;low-density lipoprotein cholesterol;high-density lipoprotein cholesterol;apolipoprotein A1;apolipoprotein B;apolipoprotein E gene;

Secondary

MeasureTime frame
oxidized low-density lipoprotein cholesterol;oxidized high-density lipoprotein cholesterol;glycosylated low-density lipoprotein cholesterol;paraoxonase;cholesterol ester transporter;lecithin cholesterol acyltransferase;metabolomics;transcriptomics;metagenomics;

Countries

China

Contacts

Public ContactHu Jingqing

Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences

gcp306@126.com+86 139 1154 6633

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026