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Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults (RIPCA)

Primary Purpose

Ischemic Preconditioning

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning equipment
Intravenous blood collection
dCA measurement
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Preconditioning focused on measuring Ischemic Preconditioning, dynamic cerebral autoregulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age from 18 to 70,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

RIPC Group

Arm Description

RIPC 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 RIPC intervention, blood collection and 7 dCA measurements.

Outcomes

Primary Outcome Measures

phase difference(PD) in degree
A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
the rate of recovery of cerebral blood flow velocity
gain in cm/s/mmHg

Secondary Outcome Measures

resistance index (RI) changes from supine to upright position
pulsatility index (PI) changes from supine to upright position
mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position

Full Information

First Posted
November 14, 2016
Last Updated
August 18, 2021
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT02965547
Brief Title
Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
Acronym
RIPCA
Official Title
Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the impact of remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.
Detailed Description
Remote ischemic preconditioning(RIPC) 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 RIPC 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
Ischemic Preconditioning
Keywords
Ischemic Preconditioning, dynamic cerebral autoregulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
RIPC Group
Arm Type
Experimental
Arm Description
RIPC 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 RIPC intervention, blood collection and 7 dCA measurements.
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning equipment
Intervention Description
The RIPC 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 and other side thigh. This intervention was undertaken one time in total.
Intervention Type
Procedure
Intervention Name(s)
Intravenous blood collection
Intervention Description
Nurses will collect intravenous blood 6ml twice(at baseline and 1h after RIPC).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
Intervention Type
Procedure
Intervention Name(s)
dCA measurement
Intervention Description
Serial measurements of dCA were performed at 7 time points, baseline, 1h, 3h, 6h, 9h, 12h, 24h after RIPC.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
phase difference(PD) in degree
Description
A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.
Time Frame
2 days
Title
the rate of recovery of cerebral blood flow velocity
Time Frame
2 days
Title
gain in cm/s/mmHg
Time Frame
2 days
Secondary Outcome Measure Information:
Title
resistance index (RI) changes from supine to upright position
Time Frame
2 days
Title
pulsatility index (PI) changes from supine to upright position
Time Frame
2 days
Title
mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age from 18 to 70,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

Citations:
PubMed Identifier
33032892
Citation
Qu Y, Liu J, Guo ZN, Zhang PD, Yan XL, Zhang P, Qi S, Yang Y. The Impact of Remote Ischaemic Conditioning on Beat-to-Beat Heart Rate Variability Circadian Rhythm in Healthy Adults. Heart Lung Circ. 2021 Apr;30(4):531-539. doi: 10.1016/j.hlc.2020.08.017. Epub 2020 Oct 5.
Results Reference
derived
PubMed Identifier
31142636
Citation
Guo ZN, Guo WT, Liu J, Chang J, Ma H, Zhang P, Zhang FL, Han K, Hu HH, Jin H, Sun X, Simpson DM, Yang Y. Changes in cerebral autoregulation and blood biomarkers after remote ischemic preconditioning. Neurology. 2019 Jul 2;93(1):e8-e19. doi: 10.1212/WNL.0000000000007732. Epub 2019 May 29. Erratum In: Neurology. 2019 Sep 24;93(13):608.
Results Reference
derived

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Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults

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