Effects of Limb Ischemic Postconditioning in Young sICAS

NCT ID: NCT02323425

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-03-31

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 twice a day for the total of 180 consecutive days.

Group Type: EXPERIMENTAL

Remote ischemic postconditioning

Intervention Type: DEVICE

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.

Control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

limb ischemic postconditioning

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Meng Wei

Director, Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GuoGang Luo, M.D/Ph.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Xunming Ji, M.D/Ph.D

Role: STUDY_DIRECTOR

Capital Medical University

Locations

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng Wei, Master

Role: CONTACT

67183723@qq.com

+8613572516964

GuoGang Luo, M.D/Ph.D

Role: CONTACT

lguogang@163.com

+8618991232449

Facility Contacts

Meng Wei, graduate

Role: primary

67183723@qq.com

+8613572516964

GuoGang Luo, M.D/Ph.D

Role: backup

lguogang@163.com

+8618991232449

Other Identifiers

XIANJ-14ZD25

Identifier Type: -

Identifier Source: org_study_id