Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults

NCT02965547 | Completed DMC

• 1 other identifier: RIPCA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Preconditioning

Keywords

Ischemic Preconditioning; dynamic cerebral autoregulation

Outcome Measures

Primary Outcomes (3)

• 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.

  2 days

• the rate of recovery of cerebral blood flow velocity

  2 days

• gain in cm/s/mmHg

  2 days

Secondary Outcomes (3)

• resistance index (RI) changes from supine to upright position

  2 days

• pulsatility index (PI) changes from supine to upright position

  2 days

• mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position

  2 days

Study Arms (1)

RIPC Group

EXPERIMENTAL

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; Procedure: Intravenous blood collection; Procedure: dCA measurement

Interventions

Remote ischemic conditioning equipment DEVICE

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.

RIPC Group

Intravenous blood collection PROCEDURE

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.

RIPC Group

dCA measurement PROCEDURE

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.

RIPC Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70,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

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (2)

• 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.

  PMID: 33032892 DERIVED

• 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.

  PMID: 31142636 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: July 25, 2017
• Last Updated: August 24, 2021

Record last verified: 2016-12

Locations

CN (1)