Clinical Research Directory

Digital Application for Stroke Health

Stroke is a leading cause of death and long-term disability worldwide. Despite substantial advances in acute stroke care, there remains a lack of evidence-based digital solutions to support patients after hospital discharge. This study evaluates the effectiveness of a digital health application (StrokeApp) designed to support patients with ischemic or hemorrhagic stroke or transient ischemic attack (TIA) in secondary prevention and recovery. In this multicenter, randomized, controlled, open-label trial, 500 patients will be assigned in a 1:1 ratio to receive either standard care alone or standard care in combination with StrokeApp. The primary objective is to assess the impact of the application on health-related quality of life three months after discharge. Secondary and exploratory outcomes include health literacy, medication adherence, vascular risk factors, health-related behaviors, psychosocial outcomes, long-term recovery up to twelve months, as well as safety and user experience.

Ambulatory Stroke Unit Treatment for Elderly Patients

ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits. Eligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design). Secondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.

Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA

This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder family in patients requiring percutaneous closure of a patent foramen ovale (PFO). Eligible participants are adults with a history of cryptogenic embolic stroke or neurologically confirmed transient ischemic attack (TIA) within the previous 12 months and a PFO suitable for transcatheter closure. A total of up to 1260 subjects will be enrolled across multiple European centers. Participants will be randomly assigned in a 3:1 ratio to receive either the Cocoon PFO Occluder (experimental group) or an Amplatzer PFO closure device (control group). The procedure will be performed as soon as possible after randomization, preferably within 14 days and no later than 45 days. The primary endpoint is a non-inferiority comparison of a composite outcome at 12 months, including recurrent ischemic stroke, TIA, or all-cause death. Secondary endpoints include PFO closure rate at 6 months, assessed by echocardiographic imaging, and other measures of safety, device performance, and clinical outcomes. The study is conducted in a single-blind fashion: patients will not be informed of the device they receive unless they explicitly request this information. Any patient who chooses to be unblinded will continue to participate without affecting eligibility or follow-up, and the date of unblinding will be documented to allow appropriate sensitivity analyses. This trial aims to provide robust comparative evidence on the clinical performance of the Cocoon PFO Occluder relative to the Amplatzer PFO Occluder to guide optimal device selection in patients with cryptogenic stroke or TIA associated with PFO.

Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent Management System

The purpose of this study is to develop a digital health-based intelligent management system for the secondary prevention of ischemic stroke and to evaluate its effectiveness through a multicenter randomized controlled trial, assessing its health economic value. Participants will receive usual care after discharge (control group) or be managed with a WeChat-based intelligent management system after discharge (intervention group). At one year, all patients will undergo face-to-face follow-up to assess clinical events, medication adherence, and the achievement of target risk factor levels.

Effect of the Intelligent Lipid Management Decision-support System on 1-year LDL-C Target Achievement in Ischemic Stroke or TIA Patients Under Evolocumab Treatment in China

This study will conduct a cluster randomized controlled trial to Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (\<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.

Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)

Inflammatory bowel diseases (IBD) are progressively increasing their prevalence worldwide. Up to half of patients may also have extraintestinal manifestation and cardiovascular diseases (CVDs) is one of the most relevant, being the second cause of death in these patients. The classical cardiovascular (CV) risk scores do not adquately capture the CV risk in IBD. We are planning a prospective observational study to evaluate patients with IBD and a gender/age-matched cohort with the aims to investigate in 2-years follow-up * Occurrence of major cardiovascular events (MACEs) in both cohorts; * Predictive factors of risk for MACEs in IBD compared to controls; * Multi-omics evaluations with the support of artificial intelligence of biomarkers associated with occurrence of MACEs in IBD

Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

The purpose of this research study is to explore whether genetic testing can offer a personalized and timely approach to assist physicians in making more informed medication decisions for stroke or high-risk transient ischemic attack (TIA) patients during their hospital stay.

Canadian TIA Score Versus ABCD2 Score in Risk Stratification of Transient Ischemic Attack (TIA)

This study aims to evaluate the superiority of a clinical score (Canadian TIA score) compared to the currently more widely used score in clinical practice (ABCD2 score) in stratifying the risk of stroke or carotid revascularization following a transient ischemic attack at 7 days, and to assess its superiority at 90 days in a European population. Patients with transient ischemic attack are at high risk of developing a subsequent stroke, especially in the short term. Identifying patients at greater risk would allow for optimized management to provide aggressive treatment within the first days following the event. All patients attending the Emergency Medicine department of this hospital will be enrolled over a consecutive 24-month period. Approximately 800 participants are expected to take part in this study. At the time of admission to the Emergency Medicine department, the various prognostic scores relevant to the study will be completed, taking about one minute. At 7 and 90 days from the date of admission, the patient will be contacted by phone and will be administered a validated questionnaire (Questionnaire for Verifying Stroke-Free Status), which will take approximately one minute.

Addressing Sleep Apnea Post-Stroke/TIA

Effectively identifying and treating risk factors for ischemic stroke and transient ischemic attack (TIA) is important to patients, their family members, and healthcare systems. While obstructive sleep apnea (OSA) is a known risk factor for stroke and TIA that is present in more than 70% of stroke/TIA survivors, testing for OSA is infrequently performed for patients and within healthcare systems. The Addressing Sleep Apnea Post-Stroke/TIA (ASAP) study intends to improve rates of guideline-recommended OSA testing and treatment through local quality improvement initiatives (QI) conducted within and across 6 VA Medical Centers. ASAP will also determine the impact of these local QI initiatives on rates of OSA diagnosis, OSA treatment, recurrent vascular events, and hospital readmissions.

Population-based Brest Stroke Registry

The registry is the main objective exhaustive list of cases validated stroke brain on a geographical area defined to calculate an incidence.