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

NCT04899362 | Completed Results DMC

• 1 other identifier: SRIC-CA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Remote Ischemic Conditioning

Keywords

Remote Ischemic Conditioning; Dynamic Cerebral Autoregulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dynamic Cerebral Autoregulation Parameter: Gain in cm/s/mmHg

  36 days

Study Arms (1)

RIC group

EXPERIMENTAL

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; Procedure: Intravenous blood collection; Device: dCA measurement

Interventions

BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China DEVICE

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.

RIC group

Intravenous blood collection PROCEDURE

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.

RIC group

dCA measurement DEVICE

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.

RIC group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Results Point of Contact

• Title: Dr Yi Yang
• Organization: the First Hospital of Jilin University

doctoryangyi@163.com

0431

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 24, 2021
• Study Start: May 20, 2021
• Primary Completion: July 19, 2021
• Study Completion: July 30, 2021
• Last Updated: January 3, 2024
• Results First Posted: December 7, 2023

Record last verified: 2021-05

Locations

CN (1)