Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning (PICNIC-ONE)
Primary Purpose
Transient Ischemic Attack, Non-disabling Stroke
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote Ischemic Conditioning
Sponsored by
About this trial
This is an interventional prevention trial for Transient Ischemic Attack focused on measuring Minor Ischemic Stroke, Transient Ischemic Attack, Remote Ischemic Conditioning
Eligibility Criteria
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.
Sites / Locations
- Xuanwu Hospital, Capital Medical University
- First Affiliated Hospital of Hainan Medical University
- Taoyuan People's Hospital
- Shengli Oilfield Center Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remote Ischemic Conditioning
Arm Description
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.
Outcomes
Primary Outcome Measures
Recurrent rate of ischemic stroke/transient ischemic stroke
Secondary Outcome Measures
Treatment-Related Adverse Events
pain and tolerability, redness, bleeding, palpitation
Compliance of remote ischemic conditioning
the proportion of patients fulfill the treatment
Incidence rate of vascular events
hemorrhage stroke, myocardial infarction and vascular death
Improvements in NIH Stroke Scale
improvements in NIH Stroke Scale in patients without recurrence or vascular events
Improvements in modified Rankin Scale
improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
Improvements in Barthel Scale
improvements in Barthel Scale in patients without recurrence or vascular events
Full Information
NCT ID
NCT03004820
First Posted
December 10, 2016
Last Updated
January 29, 2018
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03004820
Brief Title
Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 6, 2016 (Actual)
Primary Completion Date
October 19, 2017 (Actual)
Study Completion Date
October 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Ischemic Attack, Non-disabling Stroke
Keywords
Minor Ischemic Stroke, Transient Ischemic Attack, Remote Ischemic Conditioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will receive remote ischemic conditioning
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Conditioning
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Remote Ischemic Conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrent rate of ischemic stroke/transient ischemic stroke
Time Frame
within 3 months
Secondary Outcome Measure Information:
Title
Treatment-Related Adverse Events
Description
pain and tolerability, redness, bleeding, palpitation
Time Frame
within 3 months
Title
Compliance of remote ischemic conditioning
Description
the proportion of patients fulfill the treatment
Time Frame
within 3 months
Title
Incidence rate of vascular events
Description
hemorrhage stroke, myocardial infarction and vascular death
Time Frame
within 3 months
Title
Improvements in NIH Stroke Scale
Description
improvements in NIH Stroke Scale in patients without recurrence or vascular events
Time Frame
within1, 3 months
Title
Improvements in modified Rankin Scale
Description
improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
Time Frame
within 1, 3 months
Title
Improvements in Barthel Scale
Description
improvements in Barthel Scale in patients without recurrence or vascular events
Time Frame
within 1,3 months
Other Pre-specified Outcome Measures:
Title
Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months
Time Frame
within 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD, PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wuwei Feng, MD, MS
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
First Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570102
Country
China
Facility Name
Taoyuan People's Hospital
City
Changde
State/Province
Hunan
Country
China
Facility Name
Shengli Oilfield Center Hospital
City
Dongying
State/Province
Shandong
ZIP/Postal Code
257034
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29363651
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.
Results Reference
derived
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Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning
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