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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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