Clinical Research Directory

Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure

The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

The Stroke Aetiology and VascuLar Disease in Stroke and TIA Study - A Clinical Study Analysing the Effects on Cardiovascular Health and Disease With an Extended Investigation Into Conditions Causative of Stroke and Concomitant Cardiovascular Disease in Patients Admitted for Acute Stroke or TIA

Annually, about 4000 Swedes suffer a recurrent stroke, and for many, their lives change dramatically. To prevent recurring strokes, knowledge about the individual's risk of recurrence is needed to tailor an effective preventive medical treatment. The purpose of the SALSA study is to investigate whether an expanded risk assessment and subsequent treatment can reduce the recurrence of stroke in study patients. Stroke, i.e., infarction/bleeding in the brain, has several different causes that individually or together constitute the risk of recurrence. Furthermore, stroke patients often have concomitant vascular diseases in other vascular beds, which further increases the risk. Every fourth patient with acute stroke or transient ischemic attack (TIA) admitted to any of the stroke wards at Danderyd Hospital, Stockholm, Sweden, is consecutively invited to participate in the SALSA study. Those who accept the study invitation, receive an expanded investigation of the most common causes of cerebral infarction (atherosclerosis, atrial fibrillation, narrowing of the brain\'s small vessels) or brain haemorrhage (presence of the protein amyloid in the vessels, high blood pressure). Due to the high risk of stroke patients having a vascular disease, such as atherosclerosis, the presence of arterial stiffness in the aorta, 24-hour blood pressure, and blood circulation in the legs are examined at the follow-up visit. If vascular disease is detected, expanded preventive treatment is provided. Neither a general investigation of the most common stroke aetiologies in addition to the one assessed to have caused the current stroke nor examinations of other vascular beds are recommended in national stroke guidelines. In addition to the extended risk assessment, the patient will get a written treatment program tailored after the individual patient's risk profile. The compliance to this treatment program will be assessed during a return visit one year after the hospital stay. After this visit, the active participation in the study is completed for the study participant. During the remainder of the follow-up, the study participant will be followed in national medical registers. The remaining 3/4 of patients at Danderyd Hospital constitute the comparison group, who are investigated and treated according to routine and hence do not undergo the additional vascular examinations. Stroke recurrence and other cardiovascular events occurring within the next 5-10 years will be compared between study patients and the comparison group via the national stroke registry containing all stroke and TIA patients at Danderyd Hospital.

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

Somatic Dysfunction in Patients With Acute Cerebrovascular Disease

The goals of this observational study are to test the reliability of a new, standardized physical examination method to identify motion problems within joints or groups of joints among adult asymptomatic volunteers and in patients hospitalized with stroke or stroke-like episodes (e.g., transient ischemic attack, TIA). The main questions this investigation aims to answer are: * Can different, independent providers reliability quantify motion pattern problems using a systematic approach called, The Functional Pathology of the Musculoskeletal System (FPMSS) model? * Are there differences in joint(s) motion patterns among asymptomatic volunteers, patients with TIA (people with brain disease without new neurologic disability), and recent ischemic stroke (patients with new stroke-related-disability, e.g., paralysis)? * Is there an association between joint(s) motion impairment severity and stroke survivor outcomes? Participants (asymptomatic and those with stroke) will undergo a set of repeated paired, musculoskeletal physical exams by independent providers blinded to each other's assessments and patient information. Researchers will compare the severity, location, and quantity of joint(s) motion impairment between these three groups with the physical examination methodology (FPMSS). Clinical information (e.g., test results, diagnoses, brain imaging, medical history) will be collected from patients admitted for TIA and stroke. Enrolled participants with recent stroke will complete a survey three months after hospitalization to determine their self-perceived quality-of-life.

Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis

REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study

This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \& Shuttle Select Slip-Catheter (Visceral and Cerbral) for a Conformité Européenne (CE) Mark application in the European Union (EU). Additionally, the data from this study may be used to support regulatory approval in other countries/regions. The purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the Intended Use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.

The Effect of Low-dose Interleukin-2 on the Immune Landscape of Human Atherosclerotic Plaques at Single Cell Resolution.

The goal of this clinical trail is to compare the differences in carotid plaque Treg cells' gene signature for activation, proliferation, and suppressive function using scRNA-seq in patients treated with IL-2 compared to control.

Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis

An observational study to determine if individuals with increased platelet FcyRIIa will have a higher risk of ischemic events.

The Akershus Study of Ischemic Stroke and Thrombolysis -1

This observational study comprises consecutively patients with cerebrovascular diseases admitted to the Stroke Unit at Akershus University Hospital in Norway. Akershus University Hospital is the largest emergency care hospital in Norway and has a catchment area covering a population of 550.000, which is approximately 10 % of the Norwegian population and reasonably representative according to data from Statistics Norway. The hospital is public and serving both as a primary hospital and a university hospital. Due to the Norwegian, national, all-covering health-insurance, all patients enter the hospital and are considered for further in-patient care on the same conditions. The hospital has a stroke unit classified as a comprehensive stroke center according to European Stroke Organisation standards. Acute stroke management follows national and international guidelines. Overall, the ASIST-1 study will investigate management, outcome and prognosis of stroke and stroke care pathways and later follow up in primary care using several approaches combining existing clinical data from a representative population with different Norwegian health registries. Parts of the study are retrospective with prospective follow-up by health registries and parts of the study are prospective.

Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study

Two Dutch guidelines (Stroke and Cardiovascular Risk Management) provide conflicting advice on optimal statin treatment in older patients. In the SAFEST-cohort, the investigators will assess the impact of continuing versus discontinuing a statin in frail individuals aged 70 and above with a recent ischemic stroke or transient ischemic attack (TIA) on their health-related quality of life and MACE free survival during a two-year follow-up period.

Stroke Alarm Efficacy Trial

The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset. This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size. Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study. Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by: 1. recent TIA, OR 2. recent stroke without persisting arm motor deficit, OR 3. atrial fibrillation A control population matched for age, sex, NIHSS score and health care region will be identified in the Swedish national stroke registry, Riksstroke, and used for comparison. The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard.

Determining the MCID for the TOPICS-SF and PROMIS-10 in Older Patients That Suffered an Ischemic Stroke or TIA

Patient-related outcome measures (PROMs) play a crucial role in assessing patient outcomes in healthcare. Two of these PROMs are the The Older Persons and Informal Caregivers Survey Short Form (TOPICS-SF) and Patient-Reported Outcomes Measurement Information System Global Health Short Form (PROMIS-10). The investigators aim to determine the Minimal Clinically Important Difference (MCID) for the TOPICS-SF and PROMIS-10 in older people that suffered an ischemic stroke or Transient Ischemic Attack (TIA), using an anchor-based method.

Atrial Fibrillation Screening Post Ischemic Cerebrovascular Events

Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke. It is considered important to investigate the heart rhythm in stroke survivors without previously known AF, because detection of AF will prompt a change in antithrombotic treatment with subsequent lowering of the risk of recurrent stroke. There are so far very few studies on the prognostic impact of ECG investigations post stroke. Despite this knowledge gap, ECG investigation post stroke is given high priority in national and international guidelines. Considerable clinical resources are currently invested in these ECG investigations without knowledge of its utility. The investigators plan a nationwide, randomised, register-based study (RRCT) including patients aged at least 70 years receiving in-hospital care for stroke or TIA (Transient Ischemic Attack). Included patients will be randomised to standard investigation (1-2 days of ECG ) or extended ECG investigation (14 days of ECG performed at least twice). Patients diagnosed AF will be offered anticoagulation treatment. Long-term follow-up will be performed via swedish health care registers. The result of this trial will have major impact on the ECG screening recommendations for patients who have had stroke, a large group of patients with dismal prognosis.

A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States. We have completed this goal for 1993-94, 1999, 2005, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis

This study is a multicenter, double-blind, placebo-controlled, randomized clinical trial that aims to evaluate the efficacy of probucol on the reduction of the risk of recurrent stroke in patients with symptomatic intracranial or extracranial arterial stenosis.

Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）

This is a multicenter, double-blind, double-dummy, randomized clinical trial comparing the efficacy and safety of tirofiban versus placebo in preventing recurrence of stroke for patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events.

Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor

The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure, health outcomes, patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients. The main question\[s\] it aims to answer are: 1. Does providing a free home blood pressure cuff improve control of hypertension? 2. Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations? 3. Does improved control of home blood pressure decrease adverse patient outcomes? Participants will be asked to * Take their blood pressure at home and records the results * Participate in follow-up phone calls from investigators at at 3 and 6 months Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education