Ischemic StrokeREM-PROTECTNCT02169739
Remote Preconditioning Over Time To Empower Cerebral Tissue
A study testing Ischemic Preconditioning in people with Ischemic Stroke and Cerebral Small Vessel Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Previous studies in animals and humans has shown that brief periods of reduced blood flow to one organ or tissue in the body can help protect other tissues from subsequent injury caused by reduced blood flow such as a stroke. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Cerebral Small Vessel Disease, Cognitive Decline
- What is being tested?
- Ischemic Preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Mar 2020
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical
- Clinical lacunar stroke syndrome within the past 6 months
- Absence of signs or symptoms of cortical dysfunction
- No proximal large vessel atherosclerosis, intracranial atherosclerosis or cerebellar stroke.
- No major cardioembolic source requiring anticoagulation or other specific therapy
- Imaging
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- Magnetic Resonance Imaging (MRI) presence of a small subcortical ischemic, any 1 or more of:
- Diffusion-weighted imaging (DWI) lesion < 2.0cm in size at largest dimension and corresponding to the clinical syndrome.
- Well delineated focal hyperintensity <2.0 cm in size at largest dimension (including rostro-caudal extent) on FLAIR or T2 and clearly corresponding to the clinical syndrome. If other focal hyperintensities are present, the case will be discussed with the principal investigator prior to randomization
- Multiple (at least 2) hypointense lesions of size 0.3-1.5 cm at largest dimension (including rostro-caudal extent) only in the cerebral hemispheres on FLAIR or T1 in patients whose qualifying event is clinically hemispheric
- Well delinated hypointense lesion <1.5 cm in size at the largest dimension (including rostro-caudal extent) on FLAIR or T1 corresponding to the clinical syndrome. MRI must be done at least 1 months after the qualifying stroke
- Absence of cortical stroke and large (> 1.5cm) subcortical stroke, recent or remote
- White matter hyperintensity score of 2 (moderate) or 3 (severe) on the European Scale of Age-Related White Matter Change
- Absence of cerebral amyloid antipathy (CAA) as per Boston Criteria.
Who cannot join
- Disabling stroke (Rankin Scale ≥4)
- Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
- Age under 40 years
- High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc.)
- Anticipated requirement for long term use of anticoagulants (e.g. recurrent deep venous thrombosis (DVT)
- Prior cortical or retinal stroke (diagnosed either clinically or by neuroimaging), or other prior cortical or retinal transient ischemic attack (TIA)
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- Prior ipsilateral carotid endarterectomy
- Impaired renal function: estimated GFR <40
- Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
- Mini Mental Status Exam score < 24 (adjusted for age and education)
- Medical contraindication to MRI
- Pregnancy or women of child-bearing age who are not following an effective method of contraception
- Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
- SBP <90 or > 200
- Known history of limb vascular disease, limb vascular bypass surgery, or limb deep venous thrombosis
- Prisoners
- Homeless individuals
- Patient unable to give informed consent and no available legally authorized representative to provide informed consent
- Patient unlikely to be compliant with therapy/ unwilling to return for follow up visits
- Concurrent participation in another study with investigational drug or device treatment
- Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles UCLA
Los Angeles, California, 90095
About this study
Official title: Pilot, Randomized, Controlled, Staggered Start, Feasibility Trial of Ischemic Preconditioning, a Promising Novel Treatment for Stroke Prevention
Previous studies in animals and humans has shown that brief periods of reduced blood flow to one organ or tissue in the body can help protect other tissues from subsequent injury caused by reduced blood flow such as a stroke. This phenomenon is known as remote ischemic preconditioning and may help protect brain cells after a stroke. The investigators are studying a specific stroke type called subcortical stroke that is very common and has a high rate of recurrent stroke and cognition problems despite intensive prevention measures.
Read the detailed description
In this study, the investigators will enroll 60 patients. All patients will receive best standard medical therapy for 2 years. In addition, the investigators will randomly assign 40 patients to undergo daily active remote ischemic preconditioning for 1 year, and 20 patients to 1 year of standard medical therapy followed by 1 year of daily active remote ischemic preconditioning. Patient structured interviews will be performed to assess if the treatment is well tolerated and easy for stroke patients to use. Magnetic resonance (MR) pictures of the brain will be used to determine if the active treatment stops the progression of brain injury. Cognitive tests and wireless sensor technology measures will used to learn what happens to the patient's brain and body during the active treatment.
After a subject consents to participate in the study, he/she will first participate in a study screening phase to ensure a basic level of tolerability of Remote Ischemic Conditioning (autoRIC™) device. The subject will undergo one full cycle of treatment under observation of the study team, including 4 cycles of alternating 5 minute inflation and 5 minute off periods
If the subject indicates willingness to continue receiving such treatment (screening success), she/she will enter the randomized trial phase, and be randomly allocated to the treatment or control group.
If subject indicates unwillingness to continue receiving such treatment (screening failure), he/she will not advance to the randomized phase of the trial. Screen failure subjects will be followed up with a 3-day post-device screening phone call to ensure safety and obtain information regarding any adverse events.
- Being tested
- Ischemic Preconditioning
- Keywords
- ischemic preconditioning, remote ischemic preconditioning, ischemic stroke, white matter disease, cerebral small vessel disease, cognitive decline, leukoaraiosis, diffusion tensor imaging, white matter hyper intensity score, European scale of age-related white matter change
- Medical subject headings
- Ischemic Stroke, Cerebral Small Vessel Diseases, Cognitive Dysfunction, Leukoencephalopathies, Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningDevice
Patients will undergo ischemic preconditioning once or twice daily for up to four 5-minutes cycles of bilateral upper extremity ischemia separated by 5-minute periods of reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy only | No intervention | Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines. |
| Ischemic Preconditioning + Medical | Active comparator | Patients will receive treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year. The procedure will consist of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients will also receive intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines. Receives: Device: Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Adherence to Ischemic Preconditioning Procedure
Measured: 12 months
Secondary outcomes (2)
Limb Ischemia as Assessed by the Preconditioning Device
Measured: 12 months
Patient Self-reported Comfort-discomfort on a Scale of 1-5, With Lowest Score = "Very Comfortable" and 5 = "Very Uncomfortable"
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startNov 2015
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: COVID 19 restrictions
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 Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Latisha Sharma, MD, University of California, Los Angeles
- Investigators
- Latisha K Sharma, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169739
- Sponsor's protocol ID
- AHA-000-376
- Acronym
- REM-PROTECT
- Status last verified
- Mar 2021
- First submitted
- 17 Jun 2014
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomized, Controlled, Staggered Start, Feasibility Trial of Ischemic Preconditioning, a Promising Novel Treatment for Stroke Prevention
- ClinicalTrials.gov ID
- NCT02169739
- Acronym / sponsor ID
- REM-PROTECT / AHA-000-376
- Keywords
- ischemic preconditioning, remote ischemic preconditioning, ischemic stroke, white matter disease, cerebral small vessel disease, cognitive decline, leukoaraiosis, diffusion tensor imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19 restrictions
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies in animals and humans has shown that brief periods of reduced blood flow to one organ or tissue in the body can help protect other tissues from subsequent injury caused by reduced blood flow such as a stroke. This phenomenon is known as remote ischemic preconditioning and may help protect brain cells after a stroke. The investigators are studying a specific stroke type called subcortical stroke that is very common and has a high rate of recurrent stroke and cognition problems despite intensive prevention measures.
Detailed description
In this study, the investigators will enroll 60 patients. All patients will receive best standard medical therapy for 2 years. In addition, the investigators will randomly assign 40 patients to undergo daily active remote ischemic preconditioning for 1 year, and 20 patients to 1 year of standard medical therapy followed by 1 year of daily active remote ischemic preconditioning. Patient structured interviews will be performed to assess if the treatment is well tolerated and easy for stroke patients to use. Magnetic resonance (MR) pictures of the brain will be used to determine if the active treatment stops the progression of brain injury. Cognitive tests and wireless sensor technology measures will used to learn what happens to the patient's brain and body during the active treatment.
After a subject consents to participate in the study, he/she will first participate in a study screening phase to ensure a basic level of tolerability of Remote Ischemic Conditioning (autoRIC™) device. The subject will undergo one full cycle of treatment under observation of the study team, including 4 cycles of alternating 5 minute inflation and 5 minute off periods
If the subject indicates willingness to continue receiving such treatment (screening success), she/she will enter the randomized trial phase, and be randomly allocated to the treatment or control group.
If subject indicates unwillingness to continue receiving such treatment (screening failure), he/she will not advance to the randomized phase of the trial. Screen failure subjects will be followed up with a 3-day post-device screening phone call to ensure safety and obtain information regarding any adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy only | No intervention | –Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines. |
| Ischemic Preconditioning + Medical | Active comparator | Device: Ischemic PreconditioningPatients will receive treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year. The procedure will consist of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients will also receive intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Clinical
- Clinical lacunar stroke syndrome within the past 6 months
- Absence of signs or symptoms of cortical dysfunction
- No proximal large vessel atherosclerosis, intracranial atherosclerosis or cerebellar stroke.
- No major cardioembolic source requiring anticoagulation or other specific therapy
Key exclusion criteria (21 listed)
- Disabling stroke (Rankin Scale ≥4)
- Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
- Age under 40 years
- High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc.)
- Anticipated requirement for long term use of anticoagulants (e.g. recurrent deep venous thrombosis (DVT)
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 |
|---|---|---|
| Ischemic PreconditioningPatients will undergo ischemic preconditioning once or twice daily for up to four 5-minutes cycles of bilateral upper extremity ischemia separated by 5-minute periods of reperfusion. | Device | Ischemic Preconditioning + Medical |
Primary outcome
Duration of Adherence to Ischemic Preconditioning Procedure
Time frame: 12 months
2 secondary outcomes
Limb Ischemia as Assessed by the Preconditioning Device
Time frame: 12 months
Patient Self-reported Comfort-discomfort on a Scale of 1-5, With Lowest Score = "Very Comfortable" and 5 = "Very Uncomfortable"
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- 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.
Latisha K Sharma, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Preconditioning in people with Ischemic Stroke and Cerebral Small Vessel Disease, run by University of California, Los Angeles at 1 site in United States.
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 14 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Mar 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2021). 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?
Duration of Adherence to Ischemic Preconditioning Procedure (time frame: 12 months). 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 10 Mar 2021.