Cerebrovascular DiseasePhase 1/2NCT01321749
The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease
A Phase 1/2 study testing Remote ischemic preconditioning (RIPC) in people with Cerebrovascular Disease, run by Capital Medical University at 1 site in China.
Trial summary
This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Remote ischemic preconditioning (RIPC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA)
- Age between 18 to 80 years old
- Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
- National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4.
- ABCD2 score between 6 to 7
- Stable vital signs, normal hepatic and renal functions,
- No hemorrhagic tendencies.
Who cannot join
- Within 72 hrs of intra-artery or intravenous thrombolysis
- Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
- Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
- Acute myocardial infarction
- Systolic blood pressure more than 200 mmHg after drug control
- Peripheral blood vessel disease
Show all 11Show fewer
- Hematologic disease
- Severe hepatic and renal dysfunction
- Severe or unstable concomitant disease
- Cannot tolerate BLIPC or without informed consent
- Patients who did not complete the whole treatment procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Xicheng District, Beijing P.R., 100053
About this study
This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.
- Conditions
- Cerebrovascular Disease
- Being tested
- Remote ischemic preconditioning (RIPC)
- Keywords
- ischemic cerebral vascular disease, stroke secondary prevention, remote ischemic preconditioning
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioning (RIPC)Procedure or surgery
The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
| Study group | Role | What they receive |
|---|---|---|
| RIPC+stroke secondary prevension | Experimental | Procedure/Surgery: Remote Ischemic Preconditioning (RIPC) The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) Receives: Procedure: Remote ischemic preconditioning (RIPC) |
| stroke secondary prevention | No intervention | Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure and Heart Rates;
Measured: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Plasma Biomarkers of Coagulation and Fibrinolysis
blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer
Measured: the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Number of Patients Who Got New Brain Lesions
We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)
Measured: 300 days after treatment
Secondary outcomes (2)
The Time Point Until the First Stroke Recurrence,
These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.
Measured: At the 300-day after the initial treatment
Brain Perfusion Improvement Are Evaluated With SPECT and TCD
Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.
Measured: 300-day after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJan 2008
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrovascular DiseaseStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Ji Xunming, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321749
- Sponsor's protocol ID
- RIPC2011
- Status last verified
- Mar 2012
- First submitted
- 23 Mar 2011
- Last updated
- 25 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease
- ClinicalTrials.gov ID
- NCT01321749
- Acronym / sponsor ID
- RIPC2011
- Conditions
- Cerebrovascular Disease
- Keywords
- ischemic cerebral vascular disease, stroke secondary prevention, remote ischemic preconditioning
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Posted 25 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC+stroke secondary prevension | Experimental | Procedure: Remote ischemic preconditioning (RIPC)Procedure/Surgery: Remote Ischemic Preconditioning (RIPC) The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) |
| stroke secondary prevention | No intervention | –Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA)
- Age between 18 to 80 years old
- Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
- National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4.
- ABCD2 score between 6 to 7
Key exclusion criteria (11 listed)
- Within 72 hrs of intra-artery or intravenous thrombolysis
- Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
- Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
- Acute myocardial infarction
- Systolic blood pressure more than 200 mmHg after drug control
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 preconditioning (RIPC)The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. | Procedure or surgery | RIPC+stroke secondary prevension |
Primary outcome
Blood Pressure and Heart Rates;
Time frame: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Plasma Biomarkers of Coagulation and Fibrinolysis
Time frame: the time points of baseline and 1, 15 and 30 days after BLIPC treatment
blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer
Number of Patients Who Got New Brain Lesions
Time frame: 300 days after treatment
We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)
2 secondary outcomes
The Time Point Until the First Stroke Recurrence,
Time frame: At the 300-day after the initial treatment
Brain Perfusion Improvement Are Evaluated With SPECT and TCD
Time frame: 300-day after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Remote ischemic preconditioning (RIPC) in people with Cerebrovascular Disease, run by Capital Medical 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 7 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: finished, as of the sponsor's last update on 25 Apr 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure and Heart Rates; (time frame: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment). The study lists 3 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 25 Apr 2012.