LDL-c Level Variability and Trained Immunity

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Trained Immunity; Cholesterol Variability

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05790499

Atorvastatin-007

Details and patient eligibility

About

Statin treatment significantly reduces the incidence of cardiovascular events. However, cholesterol variability is associated with the risk of adverse events such as mortality, myocardial infarction, and stroke. The previous research found that the inflammatory activity of peripheral blood mononuclear cells in mice fed with intermittent high-fat diet was significantly increased, and the cholesterol variability had an impact on the trained immunity of peripheral blood mononuclear cells, thus aggravating the atherosclerosis in mice.

We plan to compare the differences in serum LDL-C levels after intermittent atorvastatin treatment and continuous atorvastatin treatment, and investigate the impact of this difference on the trained immunity of peripheral blood mononuclear cells.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Voluntarily participate, understand and sign an informed consent form;
2. Age ≥ 18 years old, male or postmenopausal female (defined as amenorrhea over 2 years with relevant clinical characteristics, such as age over 55 years old or menopausal cardiovascular symptoms such as hot flashes, night sweats, palpitations, etc.). Women with hysterectomy and/or bilateral oophorectomy may also be considered for inclusion in the group;
3. Commit to complying with research procedures and cooperate in the implementation of the entire process of research; 4、LDL-c>3.4mmol/L

Exclusion criteria

1. Previous cardiovascular history;
2. Statins should not be discontinued in high-risk groups for cardiovascular events;
3. Any known organ dysfunction;
4. Intolerance to statins;
5. Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
6. Participating in other clinical trials;
7. Unable to follow the study procedure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Atorvastatin

Experimental group

Treatment:

Drug: Atorvastatin