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

Remote Ischemic Conditioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899362
• Other study ID #: SRIC-CA
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: May 2021
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 30, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Remote Ischemic Conditioning

Intervention

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.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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