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

NCT05957523 | Recruiting

• 1 other identifier: XJTU1AF2022LSYY-428-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Preconditioning

Keywords

Remote ischemic preconditioning; Peripheral blood; Healthy adults

Outcome Measures

Primary Outcomes (3)

• Comparison of changes in various biomarkers between intermediate and intense training group

  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

  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

  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 Outcomes (4)

• Incidence of adverse events

  During day 1 to 7 of training.

• Change of faecal characteristics

  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

  Baseline (before training), during the training session (day1-7), 7th day after the end of training.

• Change of heart rates

  Baseline (before training), during the training session (day1-7), 7th day after the end of training

Study Arms (2)

Group A (high-frequency group )

EXPERIMENTAL

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

Group B (low-frequency group )

EXPERIMENTAL

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

Interventions

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.

Group A (high-frequency group ); Group B (low-frequency group )

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 45 years;
• Be in good health;
• Consent to participate in the clinical trial and sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Study Officials

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

00-86-029-85323805; liguoliang_med@163.com

Yang Yan

CONTACT

yangyan3@mail.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 24, 2023
• Study Start: June 27, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)