Clinical Trial: Remote Preconditioning Over Time To Empower Cerebral Tissue

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot, Randomized, Controlled, Staggered Start, Feasibility Trial of Ischemic Preconditioning, a Promising Novel Treatment for Stroke Prevention

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.

Detailed Summary: 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.
Sponsor: University of California, Los Angeles

Current Primary Outcome: Feasibility [ Time Frame: 12 months ]

Because the primary aim of this trial is assessing feasibility, 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety [ Time Frame: 24 months ]
    The lead safety endpoint will be all serious adverse events. Secondary safety endpoints will deep and superficial vein thrombosis and all cause mortality.
  • Biomarker Efficacy [ Time Frame: 12 months ]
    The lead efficacy endpoint will be volumetric progression of white matter ischemic injury on magnetic resonance imaging (biomarker efficacy). The primary MRI endpoint will be the proportion of patients with increase in total white matter hyperintensity volume (as percent of total brain volume) above 1.0%.


Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: June 17, 2014
Date Started: November 2015
Date Completion: June 2018
Last Updated: February 1, 2016
Last Verified: February 2016