Clinical Research Directory

Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke

Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.

Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke

The goal of this clinical trial is to learn if zastaprazan can help prevent upper gastrointestinal bleeding in adults who have recently had a transient ischemic attack (TIA) or ischemic stroke and are taking antiplatelet or anticoagulant medications. The main question it aims to answer is: \- Does zastaprazan reduce the risk of upper gastrointestinal bleeding compared to placebo in these patients? Researchers will compare zastaprazan to a placebo (a look-alike tablet that contains no drug) to see if zastaprazan works to prevent upper gastrointestinal bleeding. Participants will: * Take zastaprazan (20 mg) or a placebo once daily for the duration of the study, in addition to their prescribed antiplatelet or anticoagulant medication * Visit the study site regularly for safety monitoring, including vital signs, physical exams, and laboratory tests * Be monitored for any signs of gastrointestinal bleeding or other adverse events for up to approximately 3 years (including screening, treatment, and follow-up periods)

Pathophysiology and Risk of Atrial Fibrillation Detected After Ischemic Stroke

This prospective non-interventional cohort study investigates the pathophysiology of Atrial Fibrillation Detected After Stroke or transient ischemic attack (AFDAS) by comparing the autonomic function and inflammation between patients with AFDAS, patients with atrial fibrillation (AF) diagnosed before the ischemic event or known AF (KAF), and patients with normal sinus rhythm (NSR) after 14 day of cardiac monitoring following the event onset.

Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired clonal hematological disorder, which can cause arterial or venous thrombosis. The frequency of PNH in young patients (\< 50 years old) with embolic stroke (ESUS), transient ischemic attack (ETUS) or superior sagittal sinus cerebral venous thrombosis (SSS-CVTUS) of undetermined source, is currently unknown. This study proposes to recruit ESUS, ETUS, SSS-CVTUS patients to determine the frequency of PNH diagnosis confirmed by flow cytometry in these patient populations.

Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin as Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE

Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.

Florbetaben for Imaging of Vascular Amyloid

The Primary Objective is to determine if a new nuclear tracer (named 18F-Florbetaben) used with nuclear imaging (PET imaging) can detect inflamed plaque in patients with recent ACS or stroke/TIA.

Florida Cerebrovascular Disease Biorepository and Genomics Center

The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. The information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.

A Novel Rural Integrated Care and Early Prevention Model for Older Adults at High Risk of or Living With Stroke in China

This cluster randomized controlled trial aims to evaluate the effectiveness of a novel telemedicine-enabled integrated care model led by rural doctors in reducing cardiovascular and cerebrovascular events among elderly adults (≥65 years) at high risk of stroke in rural China. A total of 39 village clinics will be randomized to either the intervention group (digital health platform-supported integrated care) or the control group (enhanced usual care). The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for heart failure or acute coronary syndrome at 36 months.

Stroke-Card Registry

Stroke is the second leading cause of death and one of the main contributors to disability. Patients who survive the acute phase of ischemic stroke and those with transient ischemic attack (TIA) are at high risk of subsequent vascular events. Importantly, recurrent strokes are associated with a higher social and economic impact, higher case fatality, and worse clinical outcome than first-ever strokes. The burden of post-stroke complications, residual deficits, and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients. The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. After implementation of STROKE-CARD care, the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time. Furthermore the investigators aim to gain a large data-resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.

Comparison Between Non-contrast Magnetic Resonance Angiography and Carotid Doppler in Cerebrovascular Stroke

This prospective observational study aims to compare the diagnostic performance of non-contrast magnetic resonance angiography (NC-MRA) and carotid Doppler ultrasonography in the evaluation of carotid artery disease among patients with ischemic cerebrovascular stroke or transient ischemic attack. A total of 200 adult patients presenting to Sohag University Hospital will undergo both imaging modalities. The study will assess the agreement between NC-MRA and carotid Doppler in detecting and grading carotid artery stenosis according to the NASCET criteria, with the goal of evaluating the clinical utility of each technique and optimizing imaging strategies for the assessment of cerebrovascular stroke.

This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or Transient

This exploratory medical device study evaluated the arrhythmia diagnostic yield of MEMO Patch V2, a wearable patch-type electrocardiographic monitor, in adults with suspected arrhythmia who presented with symptoms such as palpitations or dizziness, or who had cryptogenic ischemic stroke or transient ischemic attack. The diagnostic yield of MEMO Patch V2 was compared with that of conventional 24-hour ambulatory electrocardiography (Holter monitoring). The study also assessed ECG signal quality, participant compliance, usability and satisfaction, and skin-related adverse events. The findings were intended to provide preliminary data for planning a future large-scale clinical study.

Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.

Radiofrequency and Cryoablation of the Posterior Wall of the Left Atrium

Atrial fibrillation (AF) is the cause of 20% of strokes, and the risk of stroke in a person suffering from this arrhythmia increases by 5 times. Ischemic stroke in patients with AF is often fatal and, compared with stroke of other etiology, leads to the most pronounced disability and more often recurs. Accordingly, the risk of death in patients with AF-related stroke is 2 times higher, and treatment costs increase 1.5 times. The main interventional method of treating AF, available in most medical institutions, is the use of radio frequency and/or cryoenergy to eliminate destructive damage to the left atrium (LA). The aim of this study is to compare two different interventional methods and identify predictors of recurrence in patients with persistent and long-term AF.

Platelet Aggregation Function-Guided De-Escalation Antiplatelet Therapy in Patients With Acute Ischemic Stroke

This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or high-risk transient ischemic attack who are sensitive to clopidogrel. Participants who present within 48 hours of symptom onset and meet the eligibility criteria will receive loading doses of clopidogrel and aspirin, followed by platelet aggregation function testing. Eligible clopidogrel-sensitive participants will be randomized to receive either 7 days of dual antiplatelet therapy followed by clopidogrel monotherapy or standard 21-day dual antiplatelet therapy followed by single antiplatelet therapy. The primary efficacy outcome is new stroke within 90 days after randomization.

Smartwatch-Guided Secondary Prevention After Stroke

After a first stroke or transient ischemic attack (TIA), the risk of recurrence is high in the weeks and months following the initial event. There are several modifiable risk factors that can reduce this risk, such as blood pressure, diet, physical activity, and smoking. Many stroke patients (NIHSS \< 5) have a low daily step count during the early recovery period, despite a good functional prognosis. Active smartwatches provide real-time feedback, track progress, and set personalized walking goals, thereby boosting motivation and adherence to physical activity recommendations. The combination of advice provided by nurses and active behavioral coaching supported by a smartwatch, compared to passive monitoring, could significantly increase daily step counts over a 12-week period. The results of this research will help guide future large-scale secondary prevention strategies integrating digital health and structured nursing support.

Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

The goal of this observational study is to * to investigate the prevalence and time course of autonomic dysfunction in acute ischemic stroke patients; * to evaluate the influence of lesion location on autonomic dysfunction; * to identify patterns of structural and functional brain connectivity within the central autonomic control circuits associated with autonomic dysfunction; and * to explore causal models of the link between brain lesions; cardiac, immunological and endocrine biomarkers; and dysautonomia. Researchers will compare patients with acute ischemic stroke to patients with transient ischemic attacks to study the effect of acute ischemic brain lesions. Participants will * undergo cardiovascular autonomic function testing; * receive structural and functional MR imaging; * provide blood samples for determinaton of serological biomarkers auf dysautonomia.

Reducing Stroke Risk in African-American Men

The project is a 6-month prospective Randomized Controlled Trial evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=80) vs. wait-list (WL, N=80) control in African American men who have experienced a stroke or TIA within the past 5 years.

Genotype Guided Antiplatelet Therapy In Ischemic Stroke

A fifth of ischemic stroke or transient ischemic attack (TIA) patients will have recurrent events within the first 3 months \[Refs 1-3\] despite aggressive medical therapy with antiplatelets and risk factor control. Clopidogrel is one of the mainstays of antiplatelet secondary prevention therapy in patients with ischemic stroke. CYP2C19 loss of function (LOF) mutations impair the effectiveness of clopidogrel \[Ref 4\]. The prevalence of LOF mutations is approximately 60% in the local population \[Ref 5\], rendering the effectiveness of empiric clopidogrel treatment doubtful. For patients who have LOF mutations, other treatment options for secondary prevention of ischemic stroke need to be tested. This study aims to determine the feasibility and clinical impact of genetic testing guided antiplatelet therapy in ischemic stroke patients on the prevention of major adverse cardiovascular or cerebrovascular events. Clopidogrel naive ischemic stroke or TIA patients aged 21 years and above will be randomised to genetic testing guided antiplatelet therapy or standard medical therapy within 7 days of their index event. Patients allocated to testing group will have blood sample drawn for diagnosis of CYP2C19 LOF mutations. Patients who test positive for an LOF mutation (intermediate and poor metabolisers) will be offered alternative antiplatelet therapy in the form of aspirn (for those who need monotherapy) or aspirin plus ticagrelor or dipyridamole (for those who need dual antiplatelet therapy) to be decided by the managing physician. Patients who test negative for LOF mutation will continue on clopidogrel. Platelet reactivity index (enables the identification of patients with an inadequate response to antiplatelet agents) will be measured at baseline.

Follow-up Extension Study of Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

This study will include the subjects with symptomatic intracranial arterial stenosis (ICAS) who have participated in and completed the 1-year follow-up of RESIST trial (NCT06615726). The aim is to observe the long-term clinical outcomes over 3 years after a 1-year regular physical exercise intervention in patients with symptomatic ICAS.

Diagnosis of Transient Ischemic Attacks in the Emergency Department

Patients presenting a Transient Ischemic Attack (TIA) and admitted to the Emergency Department should be referred to a neurovascular specialist. In recent years, several hospitals have established TIA clinics. These units are day hospitals where all the necessary examinations are performed. Access to this expertise has proven beneficial in reducing cardiovascular morbidity and mortality, particularly the risk of early recurrence. Unfortunately, this access is limited by issues of medical demographics and unequal access to the healthcare system. In practice, this ideal care is not always possible. A portion of the TIA population is at low risk, and diagnostic and therapeutic interventions are limited, not always requiring neurovascular expertise. The hypothesis of this research is that the management of a patient who has suffered a TIA (additional examinations, treatment, referral) is not linked to their cardiovascular risk and that the performance of additional examinations and therapies is incomplete.

Regular Physical Exercise in Patients With Symptomatic Intracranial Arterial Stenosis

The objective of this study is to evaluate the effectiveness and safety of regular physical exercise in preventing ischemic stroke events in patients with symptomatic intracranial arterial stenosis.

Symptomatic Carotid Outcomes Registry

The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be \<5%.

Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.

Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke

This is a randomized, controlled, outcome assessor blind, parallel group design pilot study on 100 patient with diagnosis of ischemic stroke admitted in Bou-Ali Sina Hospital, Sari,Iran.The aim of study is to compare the efficacy of 90 mg ticagrelor BID plus aspirin for 1 month and 60 mg ticagrelor BID plus aspirin for 6 months in reduce of non-disabling non-cardioembolic ischemic stroke or high risk TIA recurrence during first 12 months.