Cerebrovascular Disease

Researchers are studying patients who have had an acute ischemic stroke affecting the basal ganglia and were treated with mechanical thrombectomy. The study aims to understand how often and in what ways cognitive, motor, and sleep problems occur after this treatment. The main focus is on defining these possible dysfunctions in the short and long term after stroke treatment. The study involves patients who have undergone mechanical thrombectomy for stroke in the proximal middle cerebral artery. Participants will be evaluated using tests for cognitive function, movement abilities, and sleep disorders. Specifically, sleep will be studied through polysomnographic examinations. Assessments occur in the acute phase soon after treatment and continue through long-term follow-up. Participants will undergo testing for cognitive, motor, and sleep function within 72 hours after their stroke treatment and at later points to monitor changes over time. The primary outcome is the presence of post-stroke cognitive dysfunction measured shortly after treatment. The research team will closely observe clinical outcomes related to movement and sleep as well. The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves adult participants starting from age 18.

Carotid artery plaque rupture is a leading cause of ischemic stroke, and early, accurate assessment of plaque vulnerability can help prevent these strokes. Researchers are studying the use of 18F FDG and 68Ga-FAPI PETMR imaging to investigate features of vulnerable carotid plaques, such as active fibrosis and inflammation, which may better identify unstable plaques compared to standard MRI alone. This observational study aims to clarify imaging characteristics linked to plaque instability in patients with carotid artery plaques. Participants will undergo 18F FDG and 68Ga-FAPI PETMR scans to assess metabolic and structural plaque features. Treatments such as medication, carotid stenting, or carotid endarterectomy will follow clinical guidelines but are not assigned by the study. The study focuses on evaluating plaque vulnerability through advanced imaging rather than testing specific treatments. During the study, participants will be monitored for stroke and cerebral hemorrhage at 1, 6, and 12 months after their PETMR scan. Researchers will also assess the openness of the carotid artery lumen patency rate and analyze imaging results at these same time points. This approach aims to track plaque changes and clinical outcomes over one year to better understand plaque behavior and risk.

Atherosclerotic plaques, which are fatty build-ups in arteries, can develop silently and may rupture, leading to serious cardiovascular events like heart attacks or strokes. Despite treatments and controlling risks such as diabetes and high blood pressure, some people still develop dangerous forms of the disease. Researchers have found that plaques with thin caps, soft centers, or tiny new blood vessels are more likely to rupture, so new imaging methods are being developed to detect these vulnerable plaques earlier. This study evaluates a new 3D ultrasound probe and machine that can capture many more images than standard probes to visualize the entire plaque and its tiny blood vessels more accurately. Patients will receive an infusion of a microbubble contrast agent called SonoVue to enhance imaging. Initial 2D ultrasound images will confirm plaque presence, followed by 3D imaging using a specialized row-column array probe manipulated by a clinician. The 3D scan takes about 2 to 5 minutes and captures multiple images to assess plaque neovascularization. Participants will undergo ultrasound scans of their carotid arteries after receiving the contrast agent via an infusion. Researchers will analyze these images offline to detect new blood vessels within plaques. The main measurement is the detection of carotid plaque neovascularization at baseline. The study begins with consenting patients who have carotid plaques confirmed by previous CEUS scans. Participation involves imaging procedures and consent, with the study lasting as long as these assessments are completed.

Researchers are evaluating the use of 18FAlF-NOTA-octreotide PETMRI to study inflammation in carotid artery plaques in patients who recently had a stroke or transient ischemic attack TIA in the carotid artery area. This study aims to see if the tracer uptake in affected and unaffected carotid arteries can predict future cerebrovascular events such as recurrent TIA, stroke, or other vascular problems. The trial is conducted as a Phase 2 study at University Hospitals Leuven and focuses on patients with at least 30% stenosis in the carotid artery. Participants receive a single intravenous injection of the radioactive tracer 18FAlF-OC, dosed at 4 MBqkg, followed by a saline flush. The study has two parts in the first, five patients undergo PETMRI scans at 60, 120, and 180 minutes after injection to refine the imaging protocol. In the second part, nineteen patients receive PETMRI at the optimal time point identified earlier. Both the symptomatic culprit and non-symptomatic carotid arteries are scanned. Participants will have a screening and baseline assessment, followed by the PETMRI imaging visit. They will be contacted by telephone for follow-up interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA. Researchers will measure the standardized uptake values SUV of the tracer in the carotid arteries as the primary outcome. Secondary outcomes include the prediction of recurrent cerebrovascular events, major cardiovascular events, and overall mortality during the three-year follow-up period.

Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training CAR-ST to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions impact.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Researchers are evaluating MT200605, a drug that acts like brain-derived neurotrophic factor BDNF by protecting brain nerve tissues and supporting energy production in the brains striatum. This study focuses on patients who have had an acute ischemic stroke within 24 hours, aiming to see if MT200605 can help reduce brain injury and improve recovery. The trial is a Phase II exploratory study conducted at 32 centers in China, enrolling 360 patients. Participants will be randomly assigned to receive either a low, medium, or high dose of MT200605 or a placebo. All patients will also receive standard medical care. The study drug or placebo is given twice daily by intravenous infusion for 14 consecutive days. The trial uses a double-blind design, meaning neither participants nor researchers know which treatment is given. During the study, researchers will assess patients using the modified Rankin Scale mRS to measure disability three months after the stroke. They will also evaluate changes in the National Institutes of Health Stroke Scale NIHSS score two weeks after treatment. Safety, brain function, and recovery will be closely monitored throughout the trial, which starts in October 2025 and continues until June 2026.

Researchers are evaluating whether combining two non-invasive brain stimulation methodsmuscle stimulation of the arm using functional electrical stimulation FES and neurostimulation through the tonguecan improve recovery after stroke. This study focuses on adults who have experienced a stroke and have upper extremity motor impairments, aiming to measure changes in motor function and brain plasticity using behavioral tests and functional MRI scans. Participants are divided into several groups including stroke patients with upper extremity impairments receiving EEG-guided brain-computer interface BCI training combined with muscle and tongue stimulation, stroke patients receiving traditional rehabilitation before starting BCI-FES-tongue therapy, stroke patients receiving standard FES therapy only, healthy controls, and people with stroke risk factors. The study involves training sessions with the EEG-BCI system, muscle and tongue stimulation, and the use of the recoveriX system, which provides real-time visual and tactile feedback paired with imagined hand movements. The intervention periods vary, with some groups receiving delayed therapy and others immediate BCI therapy. Participants will undergo multiple assessments including behavioral tests of upper extremity function, EEG recordings, and functional MRI scans at the start and after about four months of therapy. The researchers will monitor changes in arm function using the Action Research Arm Test and observe brain activity changes through EEG and fMRI. The study includes up to six BCI training sessions and regular evaluations over approximately 10 weeks, with some groups receiving additional follow-up MRI and behavioral testing. Safety screening excludes those with allergies to electrode materials or contraindications for MRI, and pregnant women are not eligible.

Researchers are studying patients with carotid artery stenosis to compare the effects of ultra-intensive lipid-lowering therapy using a PCSK9 inhibitor combined with rosuvastatin or atorvastatin, with or without ezetimibe, against conventional lipid-lowering therapy using rosuvastatin or atorvastatin, with or without ezetimibe. The study aims to evaluate changes in the atherosclerotic plaque burden in these patients. Participants will either receive a combination of PCSK9 inhibitor injections every two weeks plus rosuvastatin or atorvastatin with or without ezetimibe, starting on the day of randomization, or they will continue or initiate treatment with rosuvastatin or atorvastatin with or without ezetimibe alone. The study is observational and involves two groups one exposed to the PCSK9 inhibitor plus statin treatment and the other receiving statin therapy alone. Throughout the study, participants will be monitored for changes in plaque burden at the most narrowed carotid site after about 180 days. Other assessments include lipid profiles, liver function tests, creatine kinase levels, plaque characteristics, and the occurrence of major vascular events up to 365 days. Researchers will also evaluate functional status using the modified Rankin Scale. The trial is expected to conclude in June 2027 with ongoing monitoring during the study period.

Researchers are conducting a large-scale, multicenter, prospective study to understand ischemic stroke better. The study focuses on collecting various biological samples like blood, feces, and urine from patients diagnosed with ischemic stroke to identify biomarkers linked to the condition. By combining demographic data, clinical indicators, imaging results, and biomarker information, the team aims to create models for risk assessment, early warning, and predicting patient outcomes. The study also seeks to identify key genes and explore related signaling pathways associated with ischemic stroke. Participants receive standard care, which may include intravenous thrombolysis with alteplase administered within the appropriate time window after stroke onset. The study groups include patients categorized based on prognosis as those with favorable or unfavorable outcomes. This observational study tracks patients over time without assigning specific treatments beyond usual care. Participants will undergo regular follow-up assessments, including monitoring cerebrovascular events and evaluating modified Rankin Scale scores three months after stroke onset. Various biological samples are collected to support biomarker analysis. The study involves ongoing data collection on clinical, imaging, and biological parameters to support the development of predictive models. The total duration and specific visit schedules vary by participant, with long-term follow-up planned under the study protocol.