Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT): a Single-centre, Open-label, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison of changes in various biomarkers between intermediate and intense training group
研究概览
简要总结
The aim of this study is to investigate the effects of remote ischaemic preconditioning on the peripheral blood characteristics of healthy adults and to explore the possible mechanisms for improving ischaemia/reperfusion injury and its protective effects on the cardiovascular system.
详细描述
This study plans to enroll 80 healthy adult volunteers. Of these, 60 participants will be randomly assigned in a 1:1 ratio to either a high-frequency remote ischemic preconditioning (RIPC) group or a low-frequency RIPC group, with 30 participants in each group. An additional 20 healthy volunteers will be enrolled as a non-randomized, no-intervention control group.
Participants in the high-frequency RIPC group will undergo RIPC training twice daily for seven consecutive days. Each session will consist of four cycles of 5 minutes of ischemia followed by 5 minutes of reperfusion. Participants in the low-frequency RIPC group will receive the same RIPC protocol once daily for seven consecutive days. Participants in the no-intervention control group will not receive RIPC training or any other study-related intervention.
Peripheral venous blood samples will be collected from participants in the two RIPC groups immediately before the first RIPC session, at the completion of the 7-day training period on Day 7, and seven days after completion of the training on Day 14. Participants in the no-intervention control group will undergo blood collection at the corresponding time points: baseline, Day 7, and Day 14. Relevant physiological indicators will also be recorded in accordance with the study protocol.
The study will assess longitudinal changes in peripheral blood biomarkers across the three groups and compare changes from baseline to Days 7 and 14. By including a no-intervention control group, the study aims to distinguish RIPC-related effects from natural temporal variation and other non-intervention-related changes. It will further evaluate whether different frequencies of RIPC produce distinct effects on peripheral blood biomarkers in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 45 years;
- •Be in good health;
- •Consent to participate in the clinical trial and sign the informed consent form.
排除标准
- •Abnormal results in biochemical checks and physiological indicators.
- •Cardiovascular and cerebrovascular diseases: hypertension, coronary heart disease, congenital heart disease, cerebrovascular alterations, etc.
- •Endocrine diseases: diabetes, thyroid disorders, etc.
- •Hematologic diseases: anemia, paroxysmal hemoglobinuria, primary thrombocytosis, etc.
- •Infectious diseases: hepatitis B, hepatitis C, syphilis, etc.
- •Neurological and psychiatric disorders.
- •Vascular diseases: peripheral vascular disease, Raynaud's syndrome, thromboembolic diseases.
- •Major trauma or surgery within the last six months.
- •Pregnant or breastfeeding women.
- •Upper limbs unsuitable for compression treatment: history of upper limb surgery, presence of tissue damage and limb deformity, and concomitant hemorrhagic diseases.
- •Recent circumstances that may affect results: blood donors within the last month, any medication taken within the last month, fever within the last week, women within their menstrual cycle or within 7 days before the start of menstruation.
- •Patients who refuse to sign the informed consent form for participation in this study.
研究组 & 干预措施
no-intervention control group
Participants in the no-intervention control group will not receive RIPC training or any other study-related intervention. They will undergo blood collection at the corresponding time points: baseline, Day 7, and Day 14.
Group A (high-frequency group )
Subjects aged 18 to 45 years and in good health agree to participate in the clinical trial and sign an informed consent form. The high-frequency remote ischemic preconditioning (RIPC) group will undergo RIPC training continuously for seven days, twice daily, with each session consisting of four cycles of 5 minutes of ischemia followed by 5 minutes of reperfusion.
干预措施: Remote ischaemic preconditioning (Device)
Group B (low-frequency group )
Subjects aged 18 to 45 years and in good health agree to participate in the clinical trial and sign an informed consent form. The low-frequency RIPC group will follow the same cycle and compression pattern but will train only once a day.
干预措施: Remote ischaemic preconditioning (Device)
结局指标
主要结局
Comparison of changes in various biomarkers between intermediate and intense training group
时间窗: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
Difference in collected materials from participants in group A (intermediate RIPC training, once a day) or B (intense RIPC training, twice a day)
Change of peripheral blood characteristics
时间窗: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
Peripheral blood characteristics at different remote ischemic preconditioning, training time points, including different fractions and their characteristics expressed by the results of blood tests.
Change of gut microbiome components at different remote ischemic preconditioning training time points
时间窗: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
Gut microbiome components
Changes in the expression levels of cardiovascular disease-related molecules
时间窗: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
Changes in the expression levels of cardiovascular disease-related molecules between participants in group A (intermediate RIPC training, once a day) or B (intense RIPC training, twice a day)
次要结局
- Change of faecal characteristics(Baseline (before training), the end of the training day (7th day from the start of training), 7rd day after the end of training)
- Change of heart rates(Baseline (before training), during the training session (day1-7), 7th day after the end of training)
- Incidence of adverse events(During day 1 to 7 of training.)
- Change of blood pressure(Baseline (before training), during the training session (day1-7), 7th day after the end of training.)
- Longitudinal within-group changes in the expression of cardiovascular disease-related molecules(Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training)
- Changes in the Plasma Proteomic Profile(Baseline, Day 7, and Day 14)