Non-disabling Stroke, Transient Ischemic Attack
Conditions
Keywords
Minor Ischemic Stroke, Transient Ischemic Attack, Remote Ischemic Conditioning
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.
Interventions
DEVICERemote 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.
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will receive remote ischemic conditioning
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent rate of ischemic stroke/transient ischemic stroke | within 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Improvements in NIH Stroke Scale | within1, 3 months | improvements in NIH Stroke Scale in patients without recurrence or vascular events |
Other
| Measure | Time frame |
|---|---|
| Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months | within 1 months |
Countries
China
Outcome results
None listed