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Remote Preconditioning Over Time To Empower Cerebral Tissue (REM-PROTECT)

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ClinicalTrials.gov Identifier: NCT02169739
Recruitment Status : Recruiting
First Posted : June 23, 2014
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Latisha Sharma, MD, University of California, Los Angeles

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Cerebral Small Vessel Disease Cognitive Decline Device: Ischemic Preconditioning Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot, Randomized, Controlled, Staggered Start, Feasibility Trial of Ischemic Preconditioning, a Promising Novel Treatment for Stroke Prevention
Study Start Date : November 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
No Intervention: Medical therapy only
Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
Active Comparator: Ischemic Preconditioning + Medical
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.
Device: Ischemic Preconditioning
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.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 12 months ]
    The primary endpoints are descriptive statistics describing the implementation of the RPreC procedure, including behavioral adherence to treatment, physiologic attainment of limb ischemia, and patient self-reported comfort-discomfort during treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

I. Clinical

  1. Clinical lacunar stroke syndrome within the past 6 months
  2. Absence of signs or symptoms of cortical dysfunction
  3. No proximal large vessel atherosclerosis, intracranial atherosclerosis or cerebellar stroke.
  4. No major cardioembolic source requiring anticoagulation or other specific therapy

II. Imaging

  1. Magnetic Resonance Imaging (MRI) presence of a small subcortical ischemic, any 1 or more of:

    1. Diffusion-weighted imaging (DWI) lesion < 2.0cm in size at largest dimension and corresponding to the clinical syndrome.
    2. 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
    3. 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
    4. 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
  2. Absence of cortical stroke and large (> 1.5cm) subcortical stroke, recent or remote
  3. White matter hyperintensity score of 2 (moderate) or 3 (severe) on the European Scale of Age-Related White Matter Change
  4. Absence of cerebral amyloid antipathy (CAA) as per Boston Criteria.

Exclusion Criteria:

  1. Disabling stroke (Rankin Scale ≥4)
  2. Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
  3. Age under 40 years
  4. High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc.)
  5. Anticipated requirement for long term use of anticoagulants (e.g. recurrent deep venous thrombosis (DVT)
  6. Prior cortical or retinal stroke (diagnosed either clinically or by neuroimaging), or other prior cortical or retinal transient ischemic attack (TIA)
  7. Prior ipsilateral carotid endarterectomy
  8. Impaired renal function: estimated GFR <40
  9. Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
  10. Mini Mental Status Exam score < 24 (adjusted for age and education)
  11. Medical contraindication to MRI
  12. Pregnancy or women of child-bearing age who are not following an effective method of contraception
  13. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
  14. SBP <90 or > 200
  15. Known history of limb vascular disease, limb vascular bypass surgery, or limb deep venous thrombosis
  16. Prisoners
  17. Homeless individuals
  18. Patient unable to give informed consent and no available legally authorized representative to provide informed consent
  19. Patient unlikely to be compliant with therapy/ unwilling to return for follow up visits
  20. Concurrent participation in another study with investigational drug or device treatment
  21. Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169739


Contacts
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Contact: Latisha K Sharma, MD 310-794-6379 lali@mednet.ucla.edu
Contact: Gilda Avila, BA 310-825-6930 GAvila@mednet.ucla.edu

Locations
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United States, California
University of California Los Angeles UCLA Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Latisha K Ali, MD         
Sponsors and Collaborators
University of California, Los Angeles
American Heart Association
Investigators
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Principal Investigator: Latisha K Sharma, MD University of California, Los Angeles

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Responsible Party: Latisha Sharma, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02169739     History of Changes
Other Study ID Numbers: AHA-000-376
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by Latisha Sharma, MD, University of California, Los Angeles:
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
Additional relevant MeSH terms:
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Stroke
Cerebral Small Vessel Diseases
Ischemia
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders