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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: RIC group; 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.

Device: BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China; 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.; Procedure: Intravenous blood collection; 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.; Device: dCA measurement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Cerebral Autoregulation Parameter: Phase Difference(PD) in Degree	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.	36 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg	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.	36 days

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Remote Ischemic Conditioning; Dynamic Cerebral Autoregulation
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: SRIC-CA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No