Vascular Disease

Researchers are evaluating whether the Breathlessness diagnostics in a Box (BiaB) tool can shorten the time to diagnosis for patients experiencing breathlessness compared to usual care. This prospective, interventional study uses a stepped-wedge cluster design in general practice settings across the Netherlands, Spain, and Portugal. The main goal is to see if BiaB speeds up diagnosis, with secondary aims to identify more cases of chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), and to assess the tool's usability and efficiency. The study involves 45 general practice sites that start with a usual care period and sequentially transition to using the BiaB tool. Patients receive care as part of their regular visits, either through standard diagnostic procedures or with support from BiaB. No additional treatments are mandated by the study. Each site participates for 40 weeks, and data are gathered from routine clinical visits, electronic medical records, and questionnaires completed by patients and healthcare professionals. Participants attend a single study visit and may complete up to four quarterly questionnaires over a follow-up period lasting up to one year. Researchers measure the time from first presentation of breathlessness to diagnosis, the number of new COPD and CVD diagnoses, and the usability of the BiaB tool. Data are collected continuously during the usual care and intervention phases, allowing comparison of outcomes between these periods.

Researchers are working to create risk prediction models that help identify patients with a high risk of developing serious cardiovascular problems. The study focuses on individuals with structural, rhythm-related, or inflammatory cardiovascular diseases and aims to improve early detection of those at risk. This observational study is sponsored by the Medical University Innsbruck and includes adults 18 years and older. Participants in this study have their clinical data and risk factors recorded to better understand their cardiovascular condition. There are no specific treatments or interventions given as part of the study since it is observational. The study will follow patients for up to four years to observe outcomes related to cardiovascular events and hospitalizations. During the study, researchers will monitor events such as cardiovascular mortality, stroke, heart attacks, hospital stays due to heart failure, and other severe heart-related conditions. Participants will be assessed regularly through clinical data collection without additional procedures or treatments. The study aims to gather detailed information over time to improve risk assessment and patient care for cardiovascular diseases.

Noncommunicable diseases like type 2 diabetes and cardiovascular disease cause more deaths worldwide than any other conditions, with a growing impact especially in low- and middle-income countries. Cardiovascular disease (CVD) is a leading cause of death globally, and its prevalence is rising despite awareness efforts. Diet and nutrition are important factors influencing these diseases, and this research explores the role of a traditional Chinese medicine nutritional drink in supporting cardiovascular health. The study evaluates the effects of the "Perfect Heartio" drink, a nutritional supplement made from diluted herbal extracts traditionally used in Chinese medicine. Participants will consume 15 grams of the drink twice daily for 12 weeks while their compliance is monitored. This intervention is being studied to assess its potential in improving heart and blood vessel function by measuring various cardiovascular health indicators. Participants will be assessed at the start and at weeks 4, 8, and 12 for lipid profiles, heart inflammation, heart injury, and heart remodeling. Quality of life and self-perceived health status will also be evaluated over these timepoints. The study includes healthy adults aged 18 and above who agree to follow the intervention plan and attend follow-up visits. Monitoring throughout the study will help researchers understand the drink's impact on cardiovascular health markers over the 12-week period.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

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 PET/MR 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 PET/MR 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 PET/MR 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.

This research aims to evaluate how full-arch implant-supported prostheses affect lip support in patients undergoing complex dental rehabilitation. The study focuses on how different clinical and laboratory decisions between diagnosis and prosthesis delivery may influence the prosthetic design and the patient's facial profile. Advanced 3D facial scanning and superimposition techniques allow precise measurement of vertical occlusion and lip support. Participants will undergo removal of their full-arch implant-supported prostheses, with digital facial images captured before and after this procedure using a facial scanner. This observational study leverages modern digital technology to measure changes objectively and does not involve experimental treatments. During the study, researchers will assess changes in the volume around the mouth area, distances between the lips and esthetic lines on the facial profile, and angles related to the nose and lips. These measurements occur on the same day as the prosthesis removal. The study helps improve understanding of facial changes related to dental prostheses and involves participants collaborating with the research protocol through imaging and clinical assessments.

Researchers are evaluating the use of [18F]AlF-NOTA-octreotide PET/MRI 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 [18F]AlF-OC, dosed at 4 MBq/kg, followed by a saline flush. The study has two parts: in the first, five patients undergo PET/MRI scans at 60, 120, and 180 minutes after injection to refine the imaging protocol. In the second part, nineteen patients receive PET/MRI 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 PET/MRI 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 a new 10-minute cardiovascular magnetic resonance (CMR) imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups: healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.

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.

Researchers are evaluating the safety and early effectiveness of an injectable drug called IMC-001 in improving the stability of atherosclerotic plaques in patients diagnosed with acute coronary syndrome (ACS), which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, randomized, double-blind, placebo-controlled study is being conducted at two centers and aims to better understand how IMC-001 affects plaque stability in these patients. The study involves two dose groups with nine subjects each, where six receive IMC-001 plus optimal medical therapy and three receive a placebo plus optimal medical therapy. Participants will receive injections of either IMC-001 or placebo alongside standard treatments for coronary artery disease. The trial includes a dose escalation design to assess safety and preliminary efficacy. Participants will be monitored for changes in coronary artery low-attenuation plaque volume using coronary computed tomography angiography (CCTA) at baseline and again six months after treatment. The study will track safety, plaque volume changes, and other clinical assessments during the treatment and follow-up periods. The total participation duration includes the treatment phase and a six-month evaluation after dosing to assess the primary outcome measure.