Remote Ischemic PostconditioningBAIPCNCT03335111
Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Acute Ischemic Stroke Patients
A study testing Remote Ischemic Conditioning Equipment and Intravenous blood collection in people with Remote Ischemic Postconditioning, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Influence of bilateral arm ischemic postconditioning （BAIPC）on the injury and protective blood markers and the clinical prognosis and outcome in patients with acute ischemic stroke Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Remote Ischemic Postconditioning
- What is being tested?
- Remote Ischemic Conditioning Equipment and Intravenous blood collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jan 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischemic cerebral stroke within 72 hours, NIHSS score between 4 to 15 points;
- Age between 18-80 years ,gender not limited;
- freely given informed consent.
Who cannot join
- Patients with progressive neurological disease or patients that cannot survive more than 1 year
- Patients suspected intracranial artery dissection, moyamoya disease, any known vascular inflammatory disease, radioactive vascular lesions, fibromuscular dysplasia, sickle cell disease, tumor, reversible cerebral vascular contraction and reversible posterior leukoencephalopathy syndrome
- Patients with Cardioembolism , such as rheumatic mitral or aortic stenosis, artificial heart valve, sick sinus syndrome, left atrial myxoma, left ventricular mural thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis
- Patients with uncontrollable severe hypertension (after drug treatment, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) Patients with subclavian artery stenosis 50% or higher or subclavian artery steal blood syndrome and upper limb arterial occlusion
- Patients with serum Aspertate aminotransferase or Alanine transaminase concentration 3 times higher than normal ceiling Patients that Creatinine clearance < 0.6 ml/s or serum creatinine >265 umol/l (> 3.0 mg/dl)
- Patients once with intracranial tumors or brain aneurysm, arteriovenous malformation
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- Patients with intracranial bleeding occurred within 90 days (parenchymal hemorrhage, subarachnoid hemorrhage, subdural out/epidural blood), retinal hemorrhage or visceral bleeding occurred within 30 days.
- Patients with severe blood system disease or severe blood coagulation disfunction , platelet < 100 x 109 / L;
- Patients that received major surgery 30 days before or is expected to wthin 12 months (including femoral artery, heart, the aorta or the carotid surgery);
- Patients whose Target lesion blood vessel had received a stent implantation, angioplasty or other medical treatment, or is expected to above treatments witnin 12 months ;
- Patients with BAIPC contraindications, e.g. severe soft tissue injuries, such as the upper extremity fractures or blood vessels lesions.
Trial locations and contacts
1 site in 1 country.
Jiachun Feng, MD,Phd contact
Di Ma contact
China1 site, 1 recruiting
- Recruiting
First hospital of Jilin University
Changchun, Jilin, 130000
Jiachun Feng, 86+18186871276
About this study
Official title: The Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Patients With Acute Ischemic Stroke（BAIPC）
Influence of bilateral arm ischemic postconditioning （BAIPC）on the injury and protective blood markers and the clinical prognosis and outcome in patients with acute ischemic stroke
Read the detailed description
In this study, we explore the influence of bilateral arm ischemic postconditioning (BAIPC) to patients with anterior circulation acute ischemic stroke. Patients with anterior circulation acute ischemic stroke are enrolled and divided into control group and experimental group. Patients in experimental group are administrated with BAIPC within 3 days from the occurrence of stroke. The National Institute of Health stroke scale (NIHSS) will be evaluated at different time point to analyze the influence of BAIPC to acute ischemic patients. The level of IL-4, IL-6，TNF-α as well as the frequency of different sub-populations T cells in the blood at different time point will be detected to explore the possible mechanism of BAIPC protective function.
- Conditions
- Remote Ischemic Postconditioning
- Being tested
- Remote Ischemic Conditioning Equipment, Intravenous blood collection
- Keywords
- Remote Ischemic Postconditioning, Peripheral Immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic Conditioning EquipmentOther
BAIPC is admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation) for one week.
Intravenous blood collectionProcedure or surgery
Nurses will collect 5 ml intravenous blood with anticoagulant and 5ml total blood at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial.
| Study group | Role | What they receive |
|---|---|---|
| ACI with BAIPC | Experimental | Beside of routine treatment for Anterior circulation infarction(ACI) patients, BAIPC group patients are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation). All subjects will take BAIPC for 1 week using 'Remote Ischemic Conditioning Equipment' .Intravenous blood collection with anticoagulant and 5ml total blood will be administered at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial. Receives: Procedure: Intravenous blood collection |
| ACI without BAIPC | Sham comparator | ACI patients in this group only recieve routine treatment for ischemic stroke and are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation using pressure 0 mmHg , followed by 5-minute cuff deflation). All subjects will take BAIPC for 1 week using 'Remote Ischemic Conditioning Equipment' .Intravenous blood collection with anticoagulant and 5ml total blood will be administered at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial. Receives: Other: Remote Ischemic Conditioning Equipment; Procedure: Intravenous blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pheripheral serum cytokines
We evaluate the changes of the concentration of serum cytokine (IL-4, IL-6, TNF, et.al) at 0d, 1d, 7-10d respectively to demonstrate whether acute stroke would depress the immune state of patients and wether BAIPC can influence the immune state of patients suffering acute stroke.
Measured: 0d, 1d and 7-10d
Changes of pheripheral immune cells
We evaluate the frequency of pheripheral immune cells (Th1, Th2, Th17 and Treg cells) at 0d, 1d and 7-10d to demonstrate whether acute stroke would depress the immune state of patients and wether BAIPC can influence the immune state of patients suffering acute stroke.
Measured: 0d, 1d and 7-10d
Secondary outcomes (2)
Changes of National Institute of Health Stroke scale (NIHSS)
We evaluate patients NIHSS before BAIPC and after BAIPC for one week to see wether BAIPC could improve the short term prognosis of patient.Scoring Definitions include level of consciousness, visual field, facial palsy,limb motor,sensory ,language,and dysarthria .The NIHSS captures both motor and non-motor impairments of stroke, and provides a good overview of people's deficits.NIHSS ranges from 0 to 42, with high scores corresponding to increased severity of stroke with worse prognosis.
Measured: Before BAIPC and after BAIPC for one week
Relapse of ischemic stroke
We observe the relapse of ischemic stroke after one yearto see wether BAIPC could improve the long term prognosis of patient.
Measured: one year after patients' first stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startNov 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote Ischemic PostconditioningStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- BAIPC group patients are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiachun Feng, MD,Phd, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335111
- Sponsor's protocol ID
- BAIPC
- Acronym
- BAIPC
- Status last verified
- Nov 2017
- First submitted
- 31 Jul 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Bilateral Arm Ischemic Postconditioning on Clinical Prognosis and Outcome in Patients With Acute Ischemic Stroke（BAIPC）
- ClinicalTrials.gov ID
- NCT03335111
- Acronym / sponsor ID
- BAIPC / BAIPC
- Conditions
- Remote Ischemic Postconditioning
- Keywords
- Remote Ischemic Postconditioning, Peripheral Immunity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 7 Nov 2017 (actual)
- 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.
Influence of bilateral arm ischemic postconditioning （BAIPC）on the injury and protective blood markers and the clinical prognosis and outcome in patients with acute ischemic stroke
Detailed description
In this study, we explore the influence of bilateral arm ischemic postconditioning (BAIPC) to patients with anterior circulation acute ischemic stroke. Patients with anterior circulation acute ischemic stroke are enrolled and divided into control group and experimental group. Patients in experimental group are administrated with BAIPC within 3 days from the occurrence of stroke. The National Institute of Health stroke scale (NIHSS) will be evaluated at different time point to analyze the influence of BAIPC to acute ischemic patients. The level of IL-4, IL-6，TNF-α as well as the frequency of different sub-populations T cells in the blood at different time point will be detected to explore the possible mechanism of BAIPC protective function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- BAIPC group patients are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation).
| Arm | Type | Receives |
|---|---|---|
| ACI with BAIPC | Experimental | Procedure: Intravenous blood collectionBeside of routine treatment for Anterior circulation infarction(ACI) patients, BAIPC group patients are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation). All subjects will take BAIPC for 1 week using 'Remote Ischemic Conditioning Equipment' .Intravenous blood collection with anticoagulant and 5ml total blood will be administered at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial. |
| ACI without BAIPC | Sham comparator | Other: Remote Ischemic Conditioning Equipment, Procedure: Intravenous blood collectionACI patients in this group only recieve routine treatment for ischemic stroke and are admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation using pressure 0 mmHg , followed by 5-minute cuff deflation). All subjects will take BAIPC for 1 week using 'Remote Ischemic Conditioning Equipment' .Intravenous blood collection with anticoagulant and 5ml total blood will be administered at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ischemic cerebral stroke within 72 hours, NIHSS score between 4 to 15 points;
- Age between 18-80 years ,gender not limited;
- freely given informed consent.
Key exclusion criteria (11 listed)
- Patients with progressive neurological disease or patients that cannot survive more than 1 year
- Patients suspected intracranial artery dissection, moyamoya disease, any known vascular inflammatory disease, radioactive vascular lesions, fibromuscular dysplasia, sickle cell disease, tumor, reversible cerebral vascular contraction and reversible posterior leukoencephalopathy syndrome
- Patients with Cardioembolism , such as rheumatic mitral or aortic stenosis, artificial heart valve, sick sinus syndrome, left atrial myxoma, left ventricular mural thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis
- Patients with uncontrollable severe hypertension (after drug treatment, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) Patients with subclavian artery stenosis 50% or higher or subclavian artery steal blood syndrome and upper limb arterial occlusion
- Patients with serum Aspertate aminotransferase or Alanine transaminase concentration 3 times higher than normal ceiling Patients that Creatinine clearance < 0.6 ml/s or serum creatinine >265 umol/l (> 3.0 mg/dl)
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 Conditioning EquipmentBAIPC is admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation) for one week. | Other | ACI without BAIPC |
| Intravenous blood collectionNurses will collect 5 ml intravenous blood with anticoagulant and 5ml total blood at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial. | Procedure or surgery | ACI with BAIPC, ACI without BAIPC |
Primary outcome
Changes of pheripheral serum cytokines
Time frame: 0d, 1d and 7-10d
We evaluate the changes of the concentration of serum cytokine (IL-4, IL-6, TNF, et.al) at 0d, 1d, 7-10d respectively to demonstrate whether acute stroke would depress the immune state of patients and wether BAIPC can influence the immune state of patients suffering acute stroke.
Changes of pheripheral immune cells
Time frame: 0d, 1d and 7-10d
We evaluate the frequency of pheripheral immune cells (Th1, Th2, Th17 and Treg cells) at 0d, 1d and 7-10d to demonstrate whether acute stroke would depress the immune state of patients and wether BAIPC can influence the immune state of patients suffering acute stroke.
2 secondary outcomes
Changes of National Institute of Health Stroke scale (NIHSS)
Time frame: Before BAIPC and after BAIPC for one week
Relapse of ischemic stroke
Time frame: one year after patients' first stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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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.
Jiachun Feng, MD,Phd contact
Di Ma contact
Jiachun Feng, MD,Phd study director
The First Hospital of Jilin University
1 site 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 Equipment and Intravenous blood collection in people with Remote Ischemic Postconditioning, run by The First Hospital of Jilin University at 1 site 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiachun Feng, MD,Phd (fengjcfrank@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pheripheral serum cytokines (time frame: 0d, 1d and 7-10d). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2017.