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

Not Applicable

Completed

• Conditions: Transient Ischemic Attack; Non-disabling Stroke

• Registration Number: NCT03004820
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2016-12-06
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Primary Completion: 2017-10-19
• Study Completion: 2017-10-19
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recurrent rate of ischemic stroke/transient ischemic stroke	within 3 months

Secondary Outcome Measures

Name	Time	Method
Treatment-Related Adverse Events	within 3 months	pain and tolerability, redness, bleeding, palpitation
Compliance of remote ischemic conditioning	within 3 months	the proportion of patients fulfill the treatment
Incidence rate of vascular events	within 3 months	hemorrhage stroke, myocardial infarction and vascular death
Improvements in NIH Stroke Scale	within1, 3 months	improvements in NIH Stroke Scale in patients without recurrence or vascular events
Improvements in modified Rankin Scale	within 1, 3 months	improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
Improvements in Barthel Scale	within 1,3 months	improvements in Barthel Scale in patients without recurrence or vascular events

Trial Locations

Locations (4)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, 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