Impact of Remote Ischemic Postconditioning on Autonomic Function in Stroke Patients
IRAS
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedSeptember 29, 2017
September 1, 2017
2.1 years
May 17, 2016
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart Rate Variabilities
Heart rate variability (HRV) is one of the most promising markers represent for autonomic function.We assess the changes from baseline heart rate variability to 7days and 30days.
at the time points of baseline and 7 and 30 days after treatments
Secondary Outcomes (3)
National Institutes of Health Stroke Scale(NIHSS)
at the time points of baseline and 7days after treatments.
Modified Rankin scale(mRS)
at the time points of baseline and 7,30 and 90 days after treatments
Barthel Index(BI)
at the time points of baseline and 7,30 and 90 days after treatments
Other Outcomes (2)
Stroke Recurrence
90 days after treatments
Mortality
90 days after treatments
Study Arms (2)
RIPostC
EXPERIMENTALReceiving RIPostC with pressure set at 200 mmHg. Intervention:Procedure:Remote Ischemic Postconditioning
sham RIPostC
SHAM COMPARATORReceiving sham RIPostC with pressure set at the patient's diastolic blood pressure. Intervention:Procedure:Sham Remote Ischemic Postconditioning
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Diagnosed as ischemic stroke according to the Chinese guideline of diagnosis and treatment of acute ischemic stroke 2010
- Age between 18 to 85 years old
- initial ischemic stroke within 14 days or less.
- National Institutes of Health Stroke Scale (NIHSS)score 0-15
- Modified Rankin Scale(mRS)score 1-4
- Informed consent
You may not qualify if:
- Intravenous or arterial thrombolysis, or revascularization
- Acute myocardial infarction,atrial fibrillation,arrhythmia,or cardiogenic cerebral embolism
- Systolic Blood Pressure(SBP)\>200mmHg after medication treatment
- Plasma fibrinogen\>7g/L
- Upper limb fracture or percutaneous injury
- Subclavian artery stenosis
- With severe cardiac,respiratory,hepatic,and renal dysfunction or malignant tumor
- Simultaneous participation in another interventional study
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Related Publications (1)
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.
PMID: 37329785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lin WEI, MD
Guangdong Provincial Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 19, 2016
Study Start
January 1, 2016
Primary Completion
February 1, 2018
Study Completion
December 1, 2018
Last Updated
September 29, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share