Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning

NCT ID: NCT03004820

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-06
• Study Completion Date: 2017-10-19

Brief Summary

This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.

Detailed Description

This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.

Conditions

Transient Ischemic Attack; Non-disabling Stroke

Keywords

Minor Ischemic Stroke; Transient Ischemic Attack; Remote Ischemic Conditioning

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Remote Ischemic Conditioning

RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.

Group Type: EXPERIMENTAL

Remote Ischemic Conditioning

Intervention Type: DEVICE

RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.

Interventions

Remote Ischemic Conditioning

RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Eighteen years old or older of any gender or race;

2. Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as neurologic deficit attributed to focal brain ischemia, with symptoms resolution within 24 h of symptom onset, Symptom onset is defined by the "last see normal" principle;

3. Stable vital signs, normal cardiac, hepatic and renal functions;

4. Able to consent by himself/herself or by legally authorized representative.

Exclusion Criteria

1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;

2. Modified Rankin Scale score > 2 at inclusion;

3. Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;

4. Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;

5. Clear indication for anticoagulation therapy ( cardiac source of embolus);

6. Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder, platelet count <100 × 109/L, history of drug-induced hepatic dysfunction）;

7. Any hemorrhagic transformation;

8. Gastrointestinal bleed or major surgery within 3 months of symptoms onset;

9. Stroke or TIA induced by interventional therapy or surgery;

10. Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;

11. Systolic blood pressure greater than 200 mmHg after medication;

12. Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ；

13. Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;

14. Severe noncardiovascular comorbidity with life expectancy < 3 months;

15. Pregnancy;

16. Currently receiving an investigational drug or device by other studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming

Professor, Chief Surgeon, Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xunming Ji, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Wuwei Feng, MD, MS

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Taoyuan People's Hospital

Changde, Hunan, China

Shengli Oilfield Center Hospital

Dongying, Shandong, China

Countries

China

References

Liu SM, Zhao WL, Song HQ, Meng R, Li SJ, Ren CH, Ovbiagele B, Ji XM, Feng WW. Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning. Chin Med J (Engl). 2018 Feb 5;131(3):347-351. doi: 10.4103/0366-6999.223849.

Reference Type: DERIVED

PMID: 29363651 (View on PubMed)

Other Identifiers

RICMIS/TIA

Identifier Type: -

Identifier Source: org_study_id