Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 167
- Locations
- 4
- Primary Endpoint
- Recurrent rate of ischemic stroke/transient ischemic stroke
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eighteen years old or older of any gender or race;
- •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;
- •Stable vital signs, normal cardiac, hepatic and renal functions;
- •Able to consent by himself/herself or by legally authorized representative.
Exclusion Criteria
- •Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;
- •Modified Rankin Scale score > 2 at inclusion;
- •Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;
- •Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;
- •Clear indication for anticoagulation therapy ( cardiac source of embolus);
- •Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder, platelet count <100 × 109/L, history of drug-induced hepatic dysfunction）;
- •Any hemorrhagic transformation;
- •Gastrointestinal bleed or major surgery within 3 months of symptoms onset;
- •Stroke or TIA induced by interventional therapy or surgery;
- •Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;
- •Systolic blood pressure greater than 200 mmHg after medication;
- •Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ；
- •Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;
- •Severe noncardiovascular comorbidity with life expectancy < 3 months;
- •Currently receiving an investigational drug or device by other studies.
Arms & Interventions
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.
Intervention: Remote Ischemic Conditioning (Device)
Outcomes
Primary Outcomes
Recurrent rate of ischemic stroke/transient ischemic stroke
Time Frame: within 3 months
Secondary Outcomes
- Treatment-Related Adverse Events(within 3 months)
- Compliance of remote ischemic conditioning(within 3 months)
- Incidence rate of vascular events(within 3 months)
- Improvements in NIH Stroke Scale(within1, 3 months)
- Improvements in modified Rankin Scale(within 1, 3 months)
- Improvements in Barthel Scale(within 1,3 months)
Investigators
Ji Xunming
Professor, Chief Surgeon, Vice President
Capital Medical University