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

Transient Ischemic Attack Clinical Trial

— PICNIC-ONE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004820
• Other study ID #: RICMIS/TIA
• Status: Completed
• Phase: N/A
• First received: December 10, 2016
• Last updated: January 29, 2018
• Start date: December 6, 2016
• Est. completion date: October 19, 2017

Study information

• Verified date: January 2018
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: October 19, 2017
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Non-disabling Stroke
• Stroke
• Transient Ischemic Attack

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	Taoyuan People's Hospital	Changde	Hunan
China	Shengli Oilfield Center Hospital	Dongying	Shandong
China	First Affiliated Hospital of Hainan Medical University	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months		within 1 months
Primary	Recurrent rate of ischemic stroke/transient ischemic stroke		within 3 months
Secondary	Treatment-Related Adverse Events	pain and tolerability, redness, bleeding, palpitation	within 3 months
Secondary	Compliance of remote ischemic conditioning	the proportion of patients fulfill the treatment	within 3 months
Secondary	Incidence rate of vascular events	hemorrhage stroke, myocardial infarction and vascular death	within 3 months
Secondary	Improvements in NIH Stroke Scale	improvements in NIH Stroke Scale in patients without recurrence or vascular events	within1, 3 months
Secondary	Improvements in modified Rankin Scale	improvements in modified Rankin Scale Scale in patients without recurrence or vascular events	within 1, 3 months
Secondary	Improvements in Barthel Scale	improvements in Barthel Scale in patients without recurrence or vascular events	within 1,3 months