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

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ClinicalTrials.gov Identifier: NCT02965547
Recruitment Status : Unknown
Verified December 2016 by Yi Yang, First Hospital of Jilin University.
Recruitment status was:  Not yet recruiting
First Posted : November 16, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Yi Yang, First Hospital of Jilin University

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.

Condition or disease Intervention/treatment Phase
Ischemic Preconditioning Device: Remote ischemic conditioning equipment Procedure: Intravenous blood collection Procedure: dCA measurement Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults
Study Start Date : December 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : November 2017

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)
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.




Primary Outcome Measures :
  1. 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. the rate of recovery of cerebral blood flow velocity [ Time Frame: 2 days ]
  3. gain in cm/s/mmHg [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. resistance index (RI) changes from supine to upright position [ Time Frame: 2 days ]
  2. pulsatility index (PI) changes from supine to upright position [ Time Frame: 2 days ]
  3. mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position [ Time Frame: 2 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965547


Contacts
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Contact: Yi Yang, MD,PhD doctoryangyi@163.com
Contact: Zhenni Guo, MD zhen1ni2@163.com

Sponsors and Collaborators
Yi Yang

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi Yang, Associated Dean of First Hospital of Jilin University, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02965547     History of Changes
Other Study ID Numbers: RIPCA
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Keywords provided by Yi Yang, First Hospital of Jilin University:
Ischemic Preconditioning
dynamic cerebral autoregulation
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes