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

Ischemic Preconditioning Clinical Trial

— EMINENT  

Official title:

Effects of Remote Ischemic Preconditioning on Components of Peripheral Blood and Gut Microbiome (EMINENT): a Single-centre, Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05957523
• Other study ID #: XJTU1AF2022LSK-428
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: December 12, 2024

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: 0086-029-13759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will recruit 40 healthy individuals and randomly assign them to group A or B to undergo remote ischaemic preconditioning training for 7 consecutive days, and routine biological specimens from subjects before and after the intervention will be collected. Participants in group A will be trained once a day, while those in group be will be trained twice a day. The characteristics of different fractions of blood and urine and fecal 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 feces 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Preconditioning

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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), 7rd day after the end of training
Primary	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), 7rd day after the end of training
Primary	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), 7rd day after the end of training
Secondary	Incidence of adverse events	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.
Secondary	Change of urine characteristics	Effect of RIPC training on urine characteristics, expressed by the urine 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
Secondary	Change of faecal characteristics	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
Secondary	Change of blood pressure	Changes in blood pressure at different remote ischemic preconditioning training time points, measured with sphygmomanometer.	Before and after the training in day 1,2,3,4,5,6,7 of training.
Secondary	Change of heart rates	Changes in heart rates at different remote ischemic preconditioning training time points, measured with stopwatch.	Before and after the training in day 1,2,3,4,5,6,7 of training.