Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood (EMINENT)

Study Overview
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Brief Summary
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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
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This study will recruit 50 healthy individuals to undergo remote ischaemic preconditioning training for 7 consecutive days, and routine biological specimens from subjects before and after the intervention will be collected. The characteristics of different fractions of blood and urine and faecal specimens from subjects at different time points before and after ischaemic preconditioning will be examined to investigate the effects of remote ischaemic preconditioning on the characteristics of peripheral blood, urine and faeces in healthy adults. It also provides evidence for improving the efficiency of clinical transfusion and blood conservation by comparing the differences in blood fractions under different preservation conditions.

Official Title
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Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood (EMINENT): a Single-centre, Open-label, Single-arm Clinical Trial

Conditions
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Ischemic Preconditioning

Intervention / Treatment
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* Device: Remote ischaemic preconditioning


Participation Criteria
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Eligibility Criteria
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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 of routine blood tests and biochemistry tests. Cardiovascular diseases: hypertension, coronary heart disease, congenital heart disease, cerebrovascular lesions, etc. Endocrine disorders: diabetes, thyroid disorders, etc. Hematologic disorders: anemia, paroxysmal hemoglobinuria, primary thrombocytosis, etc. Infectious diseases: hepatitis B, hepatitis C, syphilis, etc. Tumours; Neuropsychiatric disorders; Peripheral vascular diseases; Raynaud's syndrome; Thromboembolic disease; History of vascular surgery on the upper limb of the subject; Any medication taken within 1 month; History of major trauma or surgery within 6 months; History of febrile illness within 1 week; Pregnant or breastfeeding women; Patient refuses to sign the informed consent form to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy population<br>Subjects aged 18 to 45 years and in good health agree to participate in the clinical trial and sign an informed consent form. | Device: Remote ischaemic preconditioning<br>* The participant rested in the supine position for 5 minutes, then turn on the ischaemic preconditioning apparatus and place the automatically programmed blood pressure cuff on both upper arms of the participant, pressurize to 200 mmHg, pressurize for 5 minutes, rest for 5 minutes, perform 4 cycles for a total of 40 minutes each time. The training will be performed twice daily (once in the morning and once in the evening), and heart rate and blood pressure before and after each training will be recorded for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of peripheral blood characteristics | Peripheral blood characteristics at different remote ischemic preconditioning, training time points, including different fractions and their characteristics expressed by the results of blood tests. | Baseline (before training), the end of the training day (7th day from the start of training), 3rd day after the end of training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Incidence of adverse events related to remote ischemic preconditioning training. The adverse events were decided according to the medical records. | During day 1 to 7 of training. | 
| Change of urine characteristics | Effect of RIPC training on urine characteristics, expressed by the urine test results. | Baseline (before training), the end of the training day (7th day from the start of training), 3rd day after the end of training | 
| Change of faecal characteristics | Effect of RIPC training on faecal characteristics, expressed by the fecal test results. | Baseline (before training), the end of the training day (7th day from the start of training), 3rd day after the end of training | 
| Change of blood pressure | Changes in blood pressure at different remote ischemic preconditioning training time points, measured with sphygmomanometer. | Before and after the training in day 1,2,3,4,5,6,7 of training. | 
| Change of heart rates | Changes in heart rates at different remote ischemic preconditioning training time points, measured with stopwatch. | Before and after the training in day 1,2,3,4,5,6,7 of training. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote ischemic preconditioning, Peripheral blood