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

July 10, 2024 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 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.

Study Type

Interventional

Enrollment (Estimated)

60

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of changes in various biomarkers between intermediate and intense training group
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
Difference in collected materials from 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
Change of peripheral blood characteristics
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
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), 7th day after the end of training
Change of gut microbiome components at different remote ischemic preconditioning training time points
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
Gut microbiome components
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 faecal characteristics
Time Frame: Baseline (before training), the end of the training day (7th day from the start of training), 7rd day after the end of training
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), 7rd 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.
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

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 (Estimated)

December 12, 2024

Study Completion (Estimated)

December 12, 2025

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 12, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

April 1, 2024

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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