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Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood (EMINENT) (EMINENT)

Primary Purpose

Ischemic Preconditioning

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Remote ischaemic preconditioning

About this trial

This is an interventional treatment trial for Ischemic Preconditioning focused on measuring Remote ischemic preconditioning, Peripheral blood

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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 of routine blood tests and biochemistry tests. Cardiovascular diseases: hypertension, coronary heart disease, congenital heart disease, cerebrovascular lesions, etc. Endocrine disorders: diabetes, thyroid disorders, etc. Hematologic disorders: anemia, paroxysmal hemoglobinuria, primary thrombocytosis, etc. Infectious diseases: hepatitis B, hepatitis C, syphilis, etc. Tumours; Neuropsychiatric disorders; Peripheral vascular diseases; Raynaud's syndrome; Thromboembolic disease; History of vascular surgery on the upper limb of the subject; Any medication taken within 1 month; History of major trauma or surgery within 6 months; History of febrile illness within 1 week; Pregnant or breastfeeding women; Patient refuses to sign the informed consent form to participate in this study.

Sites / Locations

First Affiliated Hospital of Xian Jiantong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy population

Arm Description

Subjects aged 18 to 45 years and in good health agree to participate in the clinical trial and sign an informed consent form.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of adverse events

Incidence of adverse events related to remote ischemic preconditioning training. The adverse events were decided according to the medical records.

Change of urine characteristics

Effect of RIPC training on urine characteristics, expressed by the urine test results.

Change of faecal characteristics

Effect of RIPC training on faecal characteristics, expressed by the fecal test results.

Change of blood pressure

Changes in blood pressure at different remote ischemic preconditioning training time points, measured with sphygmomanometer.

Change of heart rates

Changes in heart rates at different remote ischemic preconditioning training time points, measured with stopwatch.

Full Information

NCT ID

NCT05957523

First Posted

June 27, 2023

Last Updated

July 20, 2023

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT05957523

Brief Title

Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood (EMINENT)

Acronym

EMINENT

Official Title

Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood (EMINENT): a Single-centre, Open-label, Single-arm Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 30, 2023 (Anticipated)

Primary Completion Date

October 12, 2023 (Anticipated)

Study Completion Date

December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study will recruit 50 healthy individuals to undergo remote ischaemic preconditioning training for 7 consecutive days, and routine biological specimens from subjects before and after the intervention will be collected. The characteristics of different fractions of blood and urine and faecal specimens from subjects at different time points before and after ischaemic preconditioning will be examined to investigate the effects of remote ischaemic preconditioning on the characteristics of peripheral blood, urine and faeces in healthy adults. It also provides evidence for improving the efficiency of clinical transfusion and blood conservation by comparing the differences in blood fractions under different preservation conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Preconditioning

Keywords

Remote ischemic preconditioning, Peripheral blood

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy population

Arm Type

Experimental

Arm Description

Subjects aged 18 to 45 years and in good health agree to participate in the clinical trial and sign an informed consent form.

Intervention Type

Device

Intervention Name(s)

Remote ischaemic preconditioning

Intervention Description

The participant 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 will be performed twice daily (once in the morning and once in the evening), and heart rate and blood pressure before and after each training will be recorded for 7 days.

Primary Outcome Measure Information:

Title

Change of peripheral blood characteristics

Description

Peripheral blood characteristics at different remote ischemic preconditioning, training time points, including different fractions and their characteristics expressed by the results of blood tests.

Time Frame

Baseline (before training), the end of the training day (7th day from the start of training), 3rd day after the end of training

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Description

Incidence of adverse events related to remote ischemic preconditioning training. The adverse events were decided according to the medical records.

Time Frame

During day 1 to 7 of training.

Title

Change of urine characteristics

Description

Effect of RIPC training on urine characteristics, expressed by the urine test results.

Time Frame

Baseline (before training), the end of the training day (7th day from the start of training), 3rd day after the end of training

Title

Change of faecal characteristics

Description

Effect of RIPC training on faecal characteristics, expressed by the fecal test results.

Time Frame

Baseline (before training), the end of the training day (7th day from the start of training), 3rd day after the end of training

Title

Change of blood pressure

Description

Changes in blood pressure at different remote ischemic preconditioning training time points, measured with sphygmomanometer.

Time Frame

Before and after the training in day 1,2,3,4,5,6,7 of training.

Title

Change of heart rates

Description

Changes in heart rates at different remote ischemic preconditioning training time points, measured with stopwatch.

Time Frame

Before and after the training in day 1,2,3,4,5,6,7 of training.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guoliang Li

Phone

0086-029-13759982523

liguoliang_med@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Yan

yangyan3@mail.xjtu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guoliang Li

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yang Yan

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affiliated Hospital of Xian Jiantong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guoliang Li

Phone

008613759982523

liguoliang_med@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood (EMINENT)

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