- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03004820
Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning (PICNIC-ONE)
January 29, 2018 updated by: Ji Xunming, Capital Medical University
Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
167
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100053
- Xuanwu Hospital, Capital Medical University
-
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Hainan
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Haikou, Hainan, China, 570102
- First Affiliated Hospital of Hainan Medical University
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Hunan
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Changde, Hunan, China
- Taoyuan People's Hospital
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Shandong
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Dongying, Shandong, China, 257034
- Shengli Oilfield Center Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- Pregnancy;
- Currently receiving an investigational drug or device by other studies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrent rate of ischemic stroke/transient ischemic stroke
Time Frame: within 3 months
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within 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-Related Adverse Events
Time Frame: within 3 months
|
pain and tolerability, redness, bleeding, palpitation
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within 3 months
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Compliance of remote ischemic conditioning
Time Frame: within 3 months
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the proportion of patients fulfill the treatment
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within 3 months
|
Incidence rate of vascular events
Time Frame: within 3 months
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hemorrhage stroke, myocardial infarction and vascular death
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within 3 months
|
Improvements in NIH Stroke Scale
Time Frame: within1, 3 months
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improvements in NIH Stroke Scale in patients without recurrence or vascular events
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within1, 3 months
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Improvements in modified Rankin Scale
Time Frame: within 1, 3 months
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improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
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within 1, 3 months
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Improvements in Barthel Scale
Time Frame: within 1,3 months
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improvements in Barthel Scale in patients without recurrence or vascular events
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within 1,3 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months
Time Frame: within 1 months
|
within 1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xunming Ji, MD, PhD, Xuanwu Hospital, Beijing
- Study Director: Wuwei Feng, MD, MS, Medical University of South Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2016
Primary Completion (Actual)
October 19, 2017
Study Completion (Actual)
October 19, 2017
Study Registration Dates
First Submitted
December 10, 2016
First Submitted That Met QC Criteria
December 23, 2016
First Posted (Estimate)
December 29, 2016
Study Record Updates
Last Update Posted (Actual)
January 31, 2018
Last Update Submitted That Met QC Criteria
January 29, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RICMIS/TIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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