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

July 20, 2026 updated by: First Affiliated Hospital Xi'an Jiaotong University

Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT): a Single-centre, Open-label, Randomized Controlled Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xian Jiantong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 and blood pressure before and after each training will be recorded for 7 days.
Experimental: 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.
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 and blood pressure before and after each training will be recorded for 7 days.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: During day 1 to 7 of training.
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 blood pressure
Time Frame: Baseline (before training), during the training session (day1-7), 7th day after the end of training.
Changes in blood pressure at different remote ischemic preconditioning training time points, measured with sphygmomanometer.
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
Changes in heart rates at different remote ischemic preconditioning training time points, measured with stopwatch.
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
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
Longitudinal within-group changes in cardiovascular disease-related molecular biomarker expression across different study time points
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
Time Frame: Baseline, Day 7, and Day 14
The relative abundance of plasma proteins will be assessed using mass spectrometry at baseline, Day 7, and Day 14. Changes from baseline and longitudinal differences among the high-frequency RIPC group, low-frequency RIPC group, and no-intervention control group will be evaluated. The no-intervention control group will help distinguish RIPC-related changes from natural temporal variation and other non-intervention-related changes.
Baseline, Day 7, and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University
  • Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Actual)

October 23, 2024

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSYY-428-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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