Bilateral Limb Ischemic PreconditioningPhase 1NCT01570231
Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians
A Phase 1 study testing bilateral limb ischemic preconditioning (Doctormate, IPC-906X) in people with Bilateral Limb Ischemic Preconditioning and Intracranial Arterial Stenosis, run by Ji Xunming at 1 site in China.
Trial summary
Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial… Read more about this study
- Who is it for?
- Ages 80 to 95 years
- Conditions the study is for
- Bilateral Limb Ischemic Preconditioning, Intracranial Arterial Stenosis
- What is being tested?
- bilateral limb ischemic preconditioning (Doctormate, IPC-906X)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2010
- Phase
- Phase 1
- 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 80 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age between 80 to 95 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 10Show fewer
- hematologic disease
- severe hepatic and renal dysfunction
- severe or unstable concomitant disease
- cannot tolerate BLIPC or without informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.
- Being tested
- bilateral limb ischemic preconditioning (Doctormate, IPC-906X)
- Keywords
- remote ischemic preconditioning, octogenarian, intracranial arterial stenosis, stroke recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral limb ischemic preconditioning (Doctormate, IPC-906X)Device
Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| bilateral limb ischemic preconditioning (BLIPC) | Experimental | 5 minutes bilateral limb ischemic preconditioning treatment with an inflating tourniquets to 200 mmHg Receives: Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X) |
| Control group | No intervention | underwent equivalent medical treatments only |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective signs of tissue or neurovascular injury
objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
Measured: 180 days after treatment
levels of plasma biomarkers
levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored
Measured: 180-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
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 Bilateral Limb Ischemic PreconditioningStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ji Xunming
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Sponsor-investigator, Ji Xunming, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570231
- Sponsor's protocol ID
- 2009
- Status last verified
- Jul 2012
- First submitted
- 25 Mar 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
Publications
Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
PubMed 25956401
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
- ClinicalTrials.gov ID
- NCT01570231
- Acronym / sponsor ID
- 2009
- Keywords
- remote ischemic preconditioning, octogenarian, intracranial arterial stenosis, stroke recurrence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ji XunmingUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Apr 2012 (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.
Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral limb ischemic preconditioning (BLIPC) | Experimental | Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X)5 minutes bilateral limb ischemic preconditioning treatment with an inflating tourniquets to 200 mmHg |
| Control group | No intervention | –underwent equivalent medical treatments only |
Who may qualify
- Ages
- 80 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- age between 80 to 95 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
Key exclusion criteria (10 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 |
|---|---|---|
| bilateral limb ischemic preconditioning (Doctormate, IPC-906X)Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment. | Device | bilateral limb ischemic preconditioning (BLIPC) |
Primary outcome
objective signs of tissue or neurovascular injury
Time frame: 180 days after treatment
objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness
levels of plasma biomarkers
Time frame: 180-day
levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored
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 27 Jul 2012.
- Derived from this study: PubMed 25956401Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6.
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 study testing bilateral limb ischemic preconditioning (Doctormate, IPC-906X) in people with Bilateral Limb Ischemic Preconditioning and Intracranial Arterial Stenosis, run by Ji Xunming 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 6 inclusion and 10 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 27 Jul 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
objective signs of tissue or neurovascular injury (time frame: 180 days after treatment). 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?
On the ClinicalTrials.gov record for NCT01570231, 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 27 Jul 2012.