Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT)

Xi'an Jiaotong University

Status: Enrolling

Conditions: Ischemic Preconditioning

Treatments: Device: Remote ischaemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05957523

XJTU1AF2022LSYY-428-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A (high-frequency group )

Experimental group

Description:

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.

Treatment:

Device: Remote ischaemic preconditioning

Group B (low-frequency group )

Experimental group

Description:

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.

Treatment:

Device: Remote ischaemic preconditioning