First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061, China
Location status: Recruiting
NCT Number: NCT05957523
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710061, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital Xi'an Jiaotong University
Other
Effects of Remote Ischemic Preconditioning on Peripheral Blood Biomarkers in Healthy Adults (EMINENT): a Single-centre, Open-label, Randomized Controlled Clinical Trial
Acronym: EMINENT
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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