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

Overview

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 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.

Interventions

• Device Remote ischaemic preconditioning
  The participants 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 for participants in group A will be performed once daily, while for participants in group B the training will be performed twice daily. And heart rate

Primary outcome measures

• Changes in the expression levels of cardiovascular disease-related molecules [Time frame: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training]

Secondary outcome measures (5)

• Longitudinal within-group changes in the expression of cardiovascular disease-related molecules [Time frame: Baseline (before training), the end of the training day (7th day from the start of training), 7th day after the end of training]
• Change of blood pressure [Time frame: Baseline (before training), during the training session (day1-7), 7th day after the end of training.]
• Change of heart rates [Time frame: Baseline (before training), during the training session (day1-7), 7th day after the end of training]
• Incidence of adverse events [Time frame: During day 1 to 7 of training.]
• Changes in the Plasma Proteomic Profile [Time frame: Baseline, Day 7, and Day 14]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• First Affiliated Hospital of Xian Jiantong University — Xi'an

Identifiers

NCT: NCT05957523 · XJTU1AF2022LSYY-428-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗