Back to resultsLDL-c Level Variability and Trained Immunity
Primary Purpose
Cholesterol Variability, Trained Immunity
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Cholesterol Variability
Eligibility Criteria
Inclusion Criteria: Voluntarily participate, understand and sign an informed consent form; 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; 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: Previous cardiovascular history; Statins should not be discontinued in high-risk groups for cardiovascular events; Any known organ dysfunction; Intolerance to statins; Pregnant women, lactating women, or women of childbearing age who do not use effective contraception; Participating in other clinical trials; Unable to follow the study procedure.
Sites / Locations
- Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atorvastatin
Arm Description
Outcomes
Primary Outcome Measures
Changes in LDL-C levels between baseline and atorvastatin treatment cycles
in the phase of atorvastatin intermittent treatment and continuous treatment
Secondary Outcome Measures
PBMCs subgroup percentage and activation status
in the phase of atorvastatin intermittent treatment and continuous treatment
PBMCs secreting cytokines
in the phase of atorvastatin intermittent treatment and continuous treatment
Differences in gene expression of PBMCs
in the phase of atorvastatin intermittent treatment and continuous treatment
The levels of hs-CRP, IL-6, IL-18, and sVCAM-1
in the phase of atorvastatin intermittent treatment and continuous treatment
Full Information
NCT ID
NCT05790499
First Posted
March 17, 2023
Last Updated
July 5, 2023
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05790499
Brief Title
LDL-c Level Variability and Trained Immunity
Official Title
Continuous Atorvastatin Therapy Compared With Intermittent Atorvastatin Therapy for the Effect of LDL-c Level Variability and the Regulation of Trained Immunity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesterol Variability, Trained Immunity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Patients are treated with atorvastatin for 2 weeks (40 mg/day), atorvastatin free for 2 weeks, atorvastatin treatment for 2 weeks, atorvastatin free for 2 weeks, a 4-week washout period (no treatment), and atorvastatin treatment for the last 4 weeks.
Primary Outcome Measure Information:
Title
Changes in LDL-C levels between baseline and atorvastatin treatment cycles
Description
in the phase of atorvastatin intermittent treatment and continuous treatment
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
PBMCs subgroup percentage and activation status
Description
in the phase of atorvastatin intermittent treatment and continuous treatment
Time Frame
16 weeks
Title
PBMCs secreting cytokines
Description
in the phase of atorvastatin intermittent treatment and continuous treatment
Time Frame
16 weeks
Title
Differences in gene expression of PBMCs
Description
in the phase of atorvastatin intermittent treatment and continuous treatment
Time Frame
16 weeks
Title
The levels of hs-CRP, IL-6, IL-18, and sVCAM-1
Description
in the phase of atorvastatin intermittent treatment and continuous treatment
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Voluntarily participate, understand and sign an informed consent form;
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;
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:
Previous cardiovascular history;
Statins should not be discontinued in high-risk groups for cardiovascular events;
Any known organ dysfunction;
Intolerance to statins;
Pregnant women, lactating women, or women of childbearing age who do not use effective contraception;
Participating in other clinical trials;
Unable to follow the study procedure.
Facility Information:
Facility Name
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Cheng, Doctor
Phone
+8602785726011
Email
nathancx@hust.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiang Cheng, Doctor
12. IPD Sharing Statement
Learn more about this trial
LDL-c Level Variability and Trained Immunity
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