Transient Ischemic AttackPICNIC-ONENCT03004820
Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning
A study testing Remote Ischemic Conditioning in people with Transient Ischemic Attack and Non-disabling Stroke, run by Capital Medical University at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Transient Ischemic Attack, Non-disabling Stroke
- What is being tested?
- Remote Ischemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 4 sitesChina
- Study dates
- 6 Dec 2016to 19 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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）;
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Taoyuan People's Hospital
Changde, Hunan
Shengli Oilfield Center Hospital
Dongying, Shandong, 257034
First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
About this study
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
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.
Read the 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.
- Conditions
- Transient Ischemic Attack, Non-disabling Stroke
- Being tested
- Remote Ischemic Conditioning
- Keywords
- Minor Ischemic Stroke, Transient Ischemic Attack, Remote Ischemic Conditioning
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic ConditioningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | 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. Receives: Device: Remote Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent rate of ischemic stroke/transient ischemic stroke
Measured: within 3 months
Secondary outcomes (6)
Treatment-Related Adverse Events
pain and tolerability, redness, bleeding, palpitation
Measured: within 3 months
Compliance of remote ischemic conditioning
the proportion of patients fulfill the treatment
Measured: within 3 months
Incidence rate of vascular events
hemorrhage stroke, myocardial infarction and vascular death
Measured: within 3 months
Improvements in NIH Stroke Scale
improvements in NIH Stroke Scale in patients without recurrence or vascular events
Measured: within1, 3 months
Improvements in modified Rankin Scale
improvements in modified Rankin Scale Scale in patients without recurrence or vascular events
Measured: within 1, 3 months
Improvements in Barthel Scale
improvements in Barthel Scale in patients without recurrence or vascular events
Measured: within 1,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start6 Dec 2016
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive remote ischemic conditioning
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
- Investigators
- Xunming Ji, MD, PhD, Principal investigator, Xuanwu Hospital, BeijingWuwei Feng, MD, MS, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004820
- Sponsor's protocol ID
- RICMIS/TIA
- Acronym
- PICNIC-ONE
- Status last verified
- Jan 2018
- First submitted
- 10 Dec 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29363651
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03004820
- Acronym / sponsor ID
- PICNIC-ONE / RICMIS/TIA
- Conditions
- Transient Ischemic Attack, Non-disabling Stroke
- Keywords
- Minor Ischemic Stroke, Transient Ischemic Attack, Remote Ischemic Conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive remote ischemic conditioning
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | Device: Remote Ischemic ConditioningRIC (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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischemic ConditioningRIC 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. | Device | Remote Ischemic Conditioning |
Primary outcome
Recurrent rate of ischemic stroke/transient ischemic stroke
Time frame: within 3 months
6 secondary outcomes
Treatment-Related Adverse Events
Time frame: within 3 months
Compliance of remote ischemic conditioning
Time frame: within 3 months
Incidence rate of vascular events
Time frame: within 3 months
Improvements in NIH Stroke Scale
Time frame: within1, 3 months
Improvements in modified Rankin Scale
Time frame: within 1, 3 months
Improvements in Barthel Scale
Time frame: within 1,3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 29363651Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xunming Ji, MD, PhD principal investigator
Xuanwu Hospital, Beijing
Wuwei Feng, MD, MS study director
Medical University of South Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischemic Conditioning in people with Transient Ischemic Attack and Non-disabling Stroke, run by Capital Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent rate of ischemic stroke/transient ischemic stroke (time frame: within 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.