LDL-c Level Variability and Trained Immunity

Not Applicable

Recruiting

• Conditions: Trained Immunity; Cholesterol Variability
• Interventions: Drug: Atorvastatin

• Registration Number: NCT05790499
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Study Start: 2023-03-20
• Study First Posted: 2023-03-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Changes in LDL-C levels between baseline and atorvastatin treatment cycles	16 weeks	in the phase of atorvastatin intermittent treatment and continuous treatment

Secondary Outcome Measures

Name	Time	Method
PBMCs secreting cytokines	16 weeks	in the phase of atorvastatin intermittent treatment and continuous treatment
The levels of hs-CRP, IL-6, IL-18, and sVCAM-1	16 weeks	in the phase of atorvastatin intermittent treatment and continuous treatment
PBMCs subgroup percentage and activation status	16 weeks	in the phase of atorvastatin intermittent treatment and continuous treatment
Differences in gene expression of PBMCs	16 weeks	in the phase of atorvastatin intermittent treatment and continuous treatment

Trial Locations

Locations (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China