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NCT Number: NCT05957523

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

Location status: Recruiting

Location contact

Guoliang Li

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischaemic preconditioning

Device

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guoliang Li

CONTACT

[email protected]

00-86-029-85323805

Yang Yan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: EMINENT

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jul 24, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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