Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients

NCT ID: NCT02777099

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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The purpose of this study is to determine whether remote ischemic postconditioning (RIPostC) initiates autonomic nervous system response and affects the prognosis in patients with acute ischemic stroke.

Detailed Description

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Remote ischemic postconditioning (RIPostC) has proven effective in reducing the ischemia-reperfusion injury. But the defensive mechanism of RIPostC still unclear. Stroke is frequently associated with autonomic dysfunction. Heart rate variability (HRV) represents the autonomic nervous system activity.This study aims to investigate whether RIPostC correlates with autonomic function and thus predicts prognosis of stroke.

Conditions

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Ischemic Stroke

Keywords

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remote ischemic postconditioning autonomic function heart rate variability acute ischemic stroke prognosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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RIPostC

Receiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning

Group Type EXPERIMENTAL

remote ischemic postconditioning

Intervention Type PROCEDURE

Remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion.The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to 200 mmHg for 5 min,and then deflating it for 5 min.Each patients in the PIPostC group will have the treatment once a day for 30 days.

sham RIPostC

Receiving sham RIPostC with pressure set at the patient's diastolic blood pressure.

Intervention:Procedure:Sham Remote Ischemic Postconditioning

Group Type SHAM_COMPARATOR

sham remote ischemic postconditioning

Intervention Type PROCEDURE

Sham remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion. The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to the patient's actual diastolic blood pressure for 5 min,and then deflating it for 5 min.Each patients in the sham PIPostC group will have the sham treatment once a day for 30 days.

Interventions

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remote ischemic postconditioning

Remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion.The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to 200 mmHg for 5 min,and then deflating it for 5 min.Each patients in the PIPostC group will have the treatment once a day for 30 days.

Intervention Type PROCEDURE

sham remote ischemic postconditioning

Sham remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion. The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to the patient's actual diastolic blood pressure for 5 min,and then deflating it for 5 min.Each patients in the sham PIPostC group will have the sham treatment once a day for 30 days.

Intervention Type PROCEDURE

Other Intervention Names

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PIPostC sham PIPostC

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed as ischemic stroke according to the Chinese guideline of diagnosis and treatment of acute ischemic stroke 2010
2. Age between 18 to 85 years old
3. initial ischemic stroke within 14 days or less.
4. National Institutes of Health Stroke Scale (NIHSS)score 0-15
5. Modified Rankin Scale(mRS)score 1-4
6. Informed consent

Exclusion Criteria

1. Intravenous or arterial thrombolysis, or revascularization
2. Acute myocardial infarction,atrial fibrillation,arrhythmia,or cardiogenic cerebral embolism
3. Systolic Blood Pressure(SBP)\>200mmHg after medication treatment
4. Plasma fibrinogen\>7g/L
5. Upper limb fracture or percutaneous injury
6. Subclavian artery stenosis
7. With severe cardiac,respiratory,hepatic,and renal dysfunction or malignant tumor
8. Simultaneous participation in another interventional study
9. Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin WEI, MD

Role: STUDY_CHAIR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lin WEI, MD

Role: CONTACT

Phone: (08620)81887233

Email: [email protected]

Miaomiao MO, Bachelor

Role: CONTACT

Phone: (08620)81887233

Email: [email protected]

Facility Contacts

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Lin WEI, MD

Role: primary

Miaomiao MO, Bachelor

Role: backup

References

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Liang H, Ye R, Zhang X, Ye H, Ouyang W, Cai S, Wei L. Autonomic function may mediate the neuroprotection of remote ischemic postconditioning in stroke: A randomized controlled trial. J Stroke Cerebrovasc Dis. 2023 Aug;32(8):107198. doi: 10.1016/j.jstrokecerebrovasdis.2023.107198. Epub 2023 Jun 15.

Reference Type DERIVED
PMID: 37329785 (View on PubMed)

Other Identifiers

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2014A020212455

Identifier Type: -

Identifier Source: org_study_id