Acute coronary syndrome is a life-threatening condition, which most commonly occurs when an atherosclerotic plaque ruptures or erodes, leading to thrombus formation within a coronary artery. A thrombus within a coronary artery can result in unstable angina, MI, or sudden death. Even after recovery from an acute episode of ACS, patients continue to be at heightened risk. The risk of recurrent CV events is high despite advances in medical therapy and standard therapeutic
regimens that have produced important improvements in the prognosis of patients with MI.
CSL112 is a novel formulation of apoA-I, the major functional component of high-density lipoprotein. It is purified from human plasma, formulated to deliver exogenous apoA-I. Apolipoprotein A-I is formulated with phosphatidylcholine (PC) and stabilized with sucrose and cholate as excipients. CSL112 is being developed for use in patients with ACS (diagnosed with either STEMI or NSTEMI) to reduce the risk of CV death, MI, and stroke upon delivery of CSL112. Evidence from the Apo-I Event Reducing in Ischemic Syndromes-I (AEGIS-I) study has demonstrated that administration of apoA-I increases cholesterol efflux in MI patients.
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events (MACE) in subjects with ACS (diagnosed with STEMI or NSTEMI), who are receiving evidence-based medical therapy.
Subjects will be randomized 1:1 to 1 of 2 treatment groups (CSL1126 g or placebo). Randomization at baseline will be stratified by subjects' index MI type (STEMI vs NSTEMI), management of the index MI (PCI vs medically managed), and region (North America, Latin America, Western Europe, Central and Eastern Europe, or Asia Pacific). The study will consist of a Screening Period, an Active
Treatment Period, and a Follow-up Period. Investigational product will be administered by intravenous (IV) infusion once weekly for 4 consecutive weeks. The primary efficacy outcome will be the composite of CV death, MI, or stroke from time of randomization through 90 days. Adverse event monitoring will continue through Visit 8 (Day 90), and all serious adverse events will be collected
through the end of the study, regardless of relationship to investigational product. Subjects will be followed for occurrence of MACE for 365 days from randomization.
Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method often used to assess connectivity between the brain and specific muscles. This research study is aimed at finding the changes in the manner brain communicates with leg muscles post-stroke and its effects on movement coordination during walking.
Constraint-induced movement therapy (CIMT) is the most efficacious treatment for children with hemiparesis from a perinatal arterial stroke but instead, weekly low-dose OT and/or PT is typical. The aims of this study are to compare 2 high doses of treatment to usual care in helping infants improve skills on the hemiplegic hand/arm and to improve bimanual activities. In addition, the association with gross motor, language and cognition will be explored.
Approximately 80% of stroke survivors have hand impairment. A majority do not fully recover their hand function despite completing standard rehabilitation. Limited hand function results in learned non-use not only of the hand but also of the whole arm. This limited upper limb movement results in decreased independence and poor quality of life. It is known that training for proper movement patterns is important especially early in rehabilitation. The purpose of this project is to determine if training using hand exoskeleton to improve finger movement is feasible in stroke patients. Stroke survivors will receive training with 4 different control strategies to improve finger joint coordination.
Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training and breathing exercises improves walking stability post-stroke.
VERIFY will validate biomarkers of upper extremity (UE) motor outcome in the acute ischemic stroke window for immediate use in clinical trials, and explore these biomarkers in acute intracerebral hemorrhage. The central hypothesis is that patients have different UE outcomes depending on corticomotor system (CMS) function, measured as motor evoked potential (MEP) status with TMS, and on CMS structure, measured as acute lesion load with MRI. VERIFY will create the first multicenter, large-scale, prospective dataset of clinical, TMS, and MRI measures in the acute stroke time window.
Sensory stimulation has been shown to enhance rehabilitation outcomes. However, most sensory stimulation devices interfere with natural hand tasks. Thus, a new wearable stimulation device has been developed to deliver imperceptible vibration to wrist skin. This study is to evaluate the community use of the device for patients with neurologic movement disorders. Participation will include wearing the provided device and charging the device every night. The knowledge regarding community use of the device may contribute to improving the device functionality and usability for future users of the device.
People who experience a stroke often have problems performing many different tasks during daily life. Most studies investigating stroke recovery and rehabilitation focus only on one type of task. The purpose of this research study is to measure individuals' function in many areas that can be affected by a stroke, such as their balance, mood, memory, reaching, and speech. This study will also track changes that can occur with task performance over time.
The purpose of this study is to identify domains in which stroke suvivors may have struggled since experiencing a stroke. These include things like emotional, family and work function. This study entails an interview and questionnaires that ask about functioning in these areas.
The longer-term goal of this work is to identify areas these areas so that we can develop a psychotherapy that could be helpful for individuals recovering from and living with the aftermath of stroke.
The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin will have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery.