NCT02323425

Brief Summary

The purpose of this study is to evaluate the protective effects of upper limb ischemic postconditioning on collateral circulationin young symptomatic intracranial atherosclerosis and the baseline characteristics of trial participants, as an open, randomized controlled, prospective controlled trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 3, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

December 17, 2014

Last Update Submit

February 1, 2017

Conditions

Stroke

Keywords

strokeRemote ischemic postconditioningsymptomatic atherosclerotic intracranial arterial stenosis

Outcome Measures

Primary Outcomes (1)

  • Mean Change of Collateral Circulation from Baseline and at 6 months

    Collateral circulation measured in iconography test: Magnetic Resonance Angiography (MRA)、 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)、Arterial spin-labeled (ASL) perfusion magnetic resonance、Transcranial Cerebral Doppler (TCD)、single photon emission computed tomography（SPECT） Baseline was defined as the onset of stroke within 48h. A higher score represents better collateral circulation status functioning.

    Baseline and at 6 months

Secondary Outcomes (2)

  • Mean Change of Symptomatic Recovery

    Baseline and at 14 days, 1 month, 6 months, and 1 year

  • Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days.

    Baseline and at 10 days

Study Arms (2)

Remote Ischemic Postconditioning

EXPERIMENTAL

remote ischemic postconditioning（RIPC） treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation twice a day for the total of 180 consecutive days.

Device: Remote ischemic postconditioning

Control

NO INTERVENTION

Patients in control group will receive foundation treatment. Foundation treatment: including blood vessel expansion、free radical elimination etc during acute phase and aspirin (100-300 mg/d), and atorvastatin (20 mg/d) till the end of the study (180 consecutive days).

Interventions

Remote ischemic postconditioningDEVICE

Remote ischemic postconditioning（RIPC）treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically.

Also known as: limb ischemic postconditioning
Remote Ischemic Postconditioning

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 45 Years old;
  • Symptomatic intracranial atherosclerotic stenosis (sICAS): cranial CTA/MRA/TCD/DSA confirm the diagnosis, patients got ischemic stroke or transient ischemic attack in the brain region supplied by the stenosis artery;
  • National Institutes of Health Stroke Scale(NIHSS) score 0-15
  • Written informed consent was signed.

You may not qualify if:

  • Cerebral hemorrhage and other parts of the active bleeding disease;
  • Severe aphasia, unable to express himself;
  • A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;
  • Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;
  • Blood Pressure\< 90 mmHg/60 mmHg or \>200 mmHg/110 mmHg after treatment;
  • Dementia and mental illness;
  • Using angiotensin-converting enzyme inhibitors;
  • A history of major surgery or trauma 4 weeks prior to admission;
  • Without informed consent.
  • Elimination Criteria：
  • Patients with poor compliance，refuse to take regular treatment and examination;
  • patients' condition get exacerbated, with NIHSS score elevate for more than 4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • GuoGang Luo, M.D/Ph.D

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Xunming Ji, M.D/Ph.D

    Capital Medical University

    STUDY DIRECTOR

Central Study Contacts

Meng Wei, Master

CONTACT

+861357251696467183723@qq.com

GuoGang Luo, M.D/Ph.D

CONTACT

+8618991232449lguogang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 23, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

February 3, 2017

Record last verified: 2017-01

Locations

CN(1)