Remote Preconditioning Over Time To Empower Cerebral Tissue

Status Terminated

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02169739
Study type	Interventional
Source	University of California, Los Angeles
Contact
Status	Terminated
Phase	N/A
Start date	November 2015
Completion date	March 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Remote Preconditioning Over Time To Empower Cerebral Tissue — REM-PROTECT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms