Clinical trial NCT03004820: Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning
Official title: Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Ischemic Attack
Non-disabling Stroke
Keywords: Minor Ischemic Stroke
Transient Ischemic Attack
Remote Ischemic Conditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will receive remote ischemic conditioning
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Recurrent rate of ischemic stroke/transient ischemic stroke
timeFrame: within 3 months
Secondary outcomes:
measure: Treatment-Related Adverse Events
timeFrame: within 3 months
measure: Compliance of remote ischemic conditioning
timeFrame: within 3 months
measure: Incidence rate of vascular events
timeFrame: within 3 months
measure: Improvements in NIH Stroke Scale
timeFrame: within1, 3 months
measure: Improvements in modified Rankin Scale
timeFrame: within 1, 3 months
measure: Improvements in Barthel Scale
timeFrame: within 1,3 months
Other outcomes:
measure: Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months
timeFrame: within 1 months
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Haikou
country: China
facility: First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Changde
country: China
facility: Taoyuan People's Hospital
state: Hunan
city: Dongying
country: China
facility: Shengli Oilfield Center Hospital
state: Shandong
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Wuwei Feng, MD, MS
role: STUDY_DIRECTOR
References:
citation: 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.