Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults

Ischemic Preconditioning Clinical Trial

— RIPCA  

Official title:

Remote Ischemic Preconditioning of Dynamic Cerebral Autoregulation in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965547
• Other study ID #: RIPCA
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 25, 2017

Study information

• Verified date: December 2016
• 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 remote ischemic preconditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 25, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Preconditioning

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the rate of recovery of cerebral blood flow velocity		2 days
Primary	gain in cm/s/mmHg		2 days
Secondary	resistance index (RI) changes from supine to upright position		2 days
Secondary	pulsatility index (PI) changes from supine to upright position		2 days
Secondary	mean middle cerebral artery blood flow velocity (mCBFV) changes from supine to upright position		2 days