The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults

Not Applicable

Completed

• Conditions: Remote Ischemic Conditioning
• Interventions: Device: BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China; Procedure: Intravenous blood collection; Device: dCA measurement

• Registration Number: NCT04899362
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

The purpose of this study is to determine the impact of serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

Detailed Description

Remote ischemic conditioning(RIC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIC provides neuro-protection by means of improving dCA.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-10
• Study Start: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-24
• Primary Completion: 2021-07-19
• Study Completion: 2021-07-30
• Results First Submitted: 2022-05-25
• Results First Submitted QC: 2023-03-01
• Results First Posted: 2023-12-07
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• age from 18 to 50,both genders
• willing to participate in follow-up visits

Exclusion Criteria

• current or having a history of chronic physical diseases or mental diseases
• suffering from infectious diseases in late one month
• pregnant and lactating women#
• smoking or drinking#
• inability to cooperate sufficiently to complete the dCA examination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RIC group	dCA measurement	RIC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation).All subjects will take 14 RIC intervention, blood collection and 10 dCA measurements.
RIC group	BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China	RIC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation).All subjects will take 14 RIC intervention, blood collection and 10 dCA measurements.
RIC group	Intravenous blood collection	RIC was induced by 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation).All subjects will take 14 RIC intervention, blood collection and 10 dCA measurements.

Primary Outcome Measures

Name	Time	Method
Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree	36 days	Dynamic cerebral autoregulation (dCA) is an important indicator of cerebrovascular function which related to the prognosis of cerebrovascular disease. DCA is usually calculated by transfer function analysis. Phase Difference (PD) is gengreated. Low PD at a low frequency band indicates impairment of autoregulation, as it suggests that cerebral blood flow velocity follows the changes in arterial blood pressure with a short delay.

Secondary Outcome Measures

Name	Time	Method
Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg	36 days	High gain at the same frequency band is also considered an indicator of compromised autoregulation for passively transferring the amplitude of arterial blood pressure to cerebral blood flow velocity.

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China