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 tools 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 drinks impact on cardiovascular health markers over the 12-week period.

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

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.

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 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.

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.