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

Primary Purpose

Remote Ischemic Conditioning

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China
Intravenous blood collection
dCA measurement
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Remote Ischemic Conditioning focused on measuring Remote Ischemic Conditioning, Dynamic Cerebral Autoregulation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RIC group

Arm Description

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.

Outcomes

Primary Outcome Measures

Dynamic cerebral autoregulation parameter: Phase Difference(PD) in Degree

Secondary Outcome Measures

Dynamic cerebral autoregulation parameter: Gain in cm/s/mmHg

Full Information

First Posted
May 10, 2021
Last Updated
October 12, 2021
Sponsor
The First Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT04899362
Brief Title
The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
Official Title
The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remote Ischemic Conditioning
Keywords
Remote Ischemic Conditioning, Dynamic Cerebral Autoregulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIC group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China
Intervention Description
The RIC consisted of 4 cycles of extremities ischemia (5-minute blood pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm. This intervention was undertaken twice a day for 7 days.
Intervention Type
Procedure
Intervention Name(s)
Intravenous blood collection
Intervention Description
Nurses will collect intravenous blood 3ml four times (at baseline and the first, seventh and eighth day of the study).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
Intervention Type
Device
Intervention Name(s)
dCA measurement
Intervention Description
Serial measurements of dCA were performed at 10 days, baseline, 1st, 2ed, 4th, 7th, 8th, 10th, 14th, 21th and 35th of the study.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis.
Primary Outcome Measure Information:
Title
Dynamic cerebral autoregulation parameter: Phase Difference(PD) in Degree
Time Frame
36 days
Secondary Outcome Measure Information:
Title
Dynamic cerebral autoregulation parameter: Gain in cm/s/mmHg
Time Frame
36 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China

12. IPD Sharing Statement

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

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