Clinical trial NCT05957523: Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT)
Official title: Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT): a Single-centre, Open-label, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Preconditioning
Keywords: Remote ischemic preconditioning
Peripheral blood
Healthy adults
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study plans to recruit 60 healthy volunteers, who will be randomly divided into a high-frequency group and a low-frequency group. 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. The low-frequency RIPC group will follow the same cycle and compression pattern but will train only once a day. Biological samples and physiological indicators will be collected from participants on the day just before the start of ischemic preconditioning training, as well as on the 7th and 14th days following the start of the training. These samples will be analyzed to identify the differences in blood components between groups and at different time points before and after RIPC. The study aims to investigate the effects of different training frequencies of RIPC on the characteristics of peripheral blood in healthy adults, as well as the changes in the peripheral blood characteristics of the participants before and after the training.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 45 years;
* Be in good health;
* Consent to participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

* 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.
* Cancer.
* 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.

Primary outcomes:
measure: Comparison of changes in various biomarkers between intermediate and intense training group
timeFrame: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
measure: Change of peripheral blood characteristics
timeFrame: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
measure: Change of gut microbiome components at different remote ischemic preconditioning training time points
timeFrame: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: During day 1 to 7 of training.
measure: Change of faecal characteristics
timeFrame: Baseline (before training), the end of the training day (7th day from the start of training), 7rd day after the end of training
measure: Change of blood pressure
timeFrame: Baseline (before training), during the training session (day1-7), 7th day after the end of training.
measure: Change of heart rates
timeFrame: Baseline (before training), during the training session (day1-7), 7th day after the end of training
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guoliang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: