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

August 18, 2021 updated by: Yi Yang
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • First Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIPC Group
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.
Device: Remote ischemic conditioning equipment
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.
Procedure: Intravenous blood collection
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.
Procedure: dCA measurement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
phase difference(PD) in degree
Time Frame: 2 days
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.
2 days
the rate of recovery of cerebral blood flow velocity
Time Frame: 2 days
2 days
gain in cm/s/mmHg
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
resistance index (RI) changes from supine to upright position
Time Frame: 2 days
2 days
pulsatility index (PI) changes from supine to upright position
Time Frame: 2 days
2 days
mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Yang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

July 25, 2017

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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