Effects of Limb Ischemic Postconditioning in Young sICAS

Stroke Clinical Trial

— EPIC-sICAS  

Official title:

Effects of Upper Limb Ischemic Postconditioning on Collateral Circulation in Young Symptomatic Intracranial Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02323425
• Other study ID #: XIANJ-14ZD25
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2014
• Last updated: February 1, 2017
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: January 2017
• Source: Health Science Center of Xi’an Jiaotong University
• Contact: Meng Wei, Master
• Phone: +8613572516964
• Email: 67183723[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Stroke is a common cardia-cerebrovascular disease with high morbidity, disability and mortality rate. And more and more young patients account for the increasing morbidity. Among them, Symptomatic intracranial atherosclerotic stenosis（sICAS）is a major cause, especially in Asians.

Currently, traditional therapeutic methods present reluctant achievements on reducing stroke recurrence and pose threat on patients'health because of invasive operation and severe side effects. Therefore, other treatment methods are called for urgently. Remote ischemic post-conditioning refers to local or distal ischemia treatment after the occurrence of cerebral ischemia. Prior research has shown that repeatedly ischemic reperfusion have protective effect on lowering the occurrence rate of ischemic events of patients with carotid stenosis. However, in-depth research on cerebral protection and correlation with collateral circulation has not been proven in an open, definitive clinical trial.

Thus, the EPIC-sICAS trial will provide important information on the protective effects of upper limb ischemic post-conditioning on collateral circulation after cerebral Infarction. Hopefully to present us a very meaningful way to improve the patient's quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 45 Years old;

2. 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;

3. National Institutes of Health Stroke Scale(NIHSS) score 0-15

4. Written informed consent was signed.

Exclusion Criteria:

1. Cerebral hemorrhage and other parts of the active bleeding disease;

2. Severe aphasia, unable to express himself;

3. A history of brain tumor, brain trauma, cerebral embolism or other brain lesions;

4. Severe lesions of severe cardiac, liver or kidney disease, malignancy or other systemic organ dysfunction;

5. Blood Pressure< 90 mmHg/60 mmHg or >200 mmHg/110 mmHg after treatment;

6. Dementia and mental illness;

7. Using angiotensin-converting enzyme inhibitors;

8. A history of major surgery or trauma 4 weeks prior to admission;

9. Without informed consent.

Elimination Criteria:

1. Patients with poor compliance,refuse to take regular treatment and examination;

2. patients' condition get exacerbated, with NIHSS score elevate for more than 4.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Remote ischemic postconditioning
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Health Science Center of Xi’an Jiaotong University	Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Change of Symptomatic Recovery	Functional test: National Institute of Health stroke scale(NIHSS)scores?Activity of Daily Living Scale (ADL) For NIHSS scores, a lower score represents better functioning. For ADL scores, a higher score represents better functioning.	Baseline and at 14 days, 1 month, 6 months, and 1 year
Secondary	Mean Change of serum vascular endothelial growth factor (VEGF) and basic Fibroblast Growth Factor (bFGF) from Baseline and at 10 days.	A higher amount represents a better outcome	Baseline and at 10 days