Remote Preconditioning Over Time To Empower Cerebral Tissue (REM-PROTECT)
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|ClinicalTrials.gov Identifier: NCT02169739|
Recruitment Status : Suspended (COVID 19 restrictions)
First Posted : June 23, 2014
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Cerebral Small Vessel Disease Cognitive Decline||Device: Ischemic Preconditioning||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pilot, Randomized, Controlled, Staggered Start, Feasibility Trial of Ischemic Preconditioning, a Promising Novel Treatment for Stroke Prevention|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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.
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
|United States, California|
|University of California Los Angeles UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Latisha K Sharma, MD||University of California, Los Angeles|