Clinical Research Directory

Vascular Inflammation in Atherosclerosis - Whole Body Molecular PET/CT Imaging Using Folate Receptor β

This study investigates inflammation in the blood vessels of people with coronary artery disease (CAD) or a recent myocardial infarction. Inflammation plays an important role in the development and progression of atherosclerosis, but there is currently no established clinical imaging method for detecting inflammation in atherosclerotic plaques throughout the body. The study uses a new PET imaging tracer called 18F-AlF-NOTA-Folate. The tracer is designed to bind to folate receptor beta (FR-β), a marker found on activated macrophages, which are immune cells involved in inflammation. The aim is to determine whether PET imaging with this tracer can detect and measure inflammation in atherosclerotic plaques. Approximately 90 patients will participate. One group will include patients with suspected or stable coronary artery disease who are undergoing coronary CT angiography and PET imaging as part of their clinical assessment. A second, smaller group will include patients who have recently had a myocardial infarction. Participants will undergo PET and CT imaging and provide blood samples. The imaging will examine the coronary arteries and other major arteries, including the carotid arteries, aorta and iliac arteries. The study will also investigate blood flow in the heart and other organs and examine the relationship between vascular inflammation, atherosclerotic plaque characteristics and markers of inflammation in the blood. The study is not testing a treatment for coronary artery disease. The folate tracer is administered only for imaging purposes. Participants will be followed through hospital and registry records for up to five years to investigate whether imaging findings are associated with later cardiovascular events. The study may provide new information about how inflammation is distributed in atherosclerosis and whether FR-β-targeted PET imaging could be useful for detecting and studying vascular inflammation in patients with cardiovascular disease.

wCAR-Austria: A Women-Specific Score to Assess Cardiovascular Risk in Women Aged 40 to 65

The wCAR-Austria Study is a multicentre, prospective, interventional study evaluating a novel women-specific cardiovascular risk score (wCAR) in 800 women aged 40-65 years across Austria. The wCAR score integrates conventional and women-specific cardiovascular risk factors - including hypertensive disorders of pregnancy, gestational diabetes, premature ovarian insufficiency, autoimmune disease, and menopause stage - into a three-axis, multiplicatively modular architecture. The study consists of two phases: A randomised, controlled interventional substudy (wCAR-CARE, PROBE design) allocates all participants with wCAR ≥ 11 points 1:1 to a structured precision-prevention arm (arm A, including tailored lifestyle intervention, structured statin evaluation, and menopausal hormone therapy counselling within the "window of opportunity") versus guideline-directed standard of care (arm B) for 24 months. Co-primary endpoints of Phase A are the area under the receiver-operating-characteristic curve (AUC) of the wCAR score for any coronary plaque (including non-calcified soft plaque on CCTA) in the intermediate stratum (E1a, n=100) and in the combined intermediate + high strata (E1b, n=200), analysed under a Bonferroni-Holm closed-testing procedure. The co-primary endpoint of wCAR-CARE is a composite risk-factor endpoint at month 24. The primary Phase B endpoint is time to first MACE. Secondary endpoints include reclassification improvement of wCAR versus SCORE2 and PREVENT, convergence validation against age-adjusted NT-proBNP percentiles, and convergence validation against high-sensitivity troponin-T using sex-specific thresholds per the Fifth Universal Definition of Myocardial Infarction (Mills et al., 2026).

Atherosclerosis in Early Rheumatoid Arthritis Patients Using Atherogenic Index of the Plasma and Carotid Intima Media Thickness

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease primarily affecting the peripheral joints, yet its extra-articular burden particularly on the cardiovascular (CV) system has emerged as its most consequential long-term complication . Cardiovascular disease (CVD) accounts for 40% of all deaths in RA patients, making it the leading cause of mortality .This excess CV risk is estimated to be 1.5 to 2 times higher than in the general population .The overall CV risk conferred by RA has been linked in magnitude to that of diabetes mellitus, underscoring RA as an independent cardiovascular risk factor formally recognised in the 2021 European Society of Cardiology Guidelines on CVD prevention . In this context, the non-invasive detection of preclinical atherosclerosis before the onset of clinical CV events has become clinical priority. Carotid intima-media thickness (CIMT), measured by high-resolution B-mode ultrasonography, is a well-validated surrogate marker of early structural arterial wall changes that independently predicts future myocardial infarction and stroke .Multiple studies have documented significantly elevated CIMT in RA patients compared with age- and sex-matched controls; studies found higher CIMT values across all age groups in RA, with values increasing in proportion to disease severity as assessed by the Disease Activity Score in 28 joints . The atherogenic index of plasma (AIP) defined as the base-10 logarithm of the triglyceride-to-HDL-cholesterol ratio has emerged as a calculated composite biomarker reflecting lipoprotein particle atherogenicity, particularly the preponderance of small, dense LDL particles .A high AIP (\>0.21) has been independently associated with major adverse cardiovascular events beyond the predictive capacity of conventional lipid panels .

Development and Validation of a Scale of Propensity for Change in Chronic Disease Prevention

Modifiable risk factors are estimated to account for 70% of cardiovascular diseases, 40% of Alzheimer's-type dementias, and 50% of type 2 diabetes cases. Numerous trials have evaluated interventions aimed at modifying these risk factors, whether through the promotion of healthy lifestyle choices (diet, physical activity, etc.) or specific activities (cognitive training, etc.). However, these trials have yielded inconsistent or modest results, potentially due to a failure to adopt the recommended lifestyle changes. To better tailor prevention interventions, it is therefore essential to have scales available that measure the barriers to and facilitators of lifestyle change. The aim of this study is to develop and validate a Patient-Reported Outcome Measure (PROM) to assess the barriers to and facilitators of change following participation in a prevention program. The scale will be structured into three sub-scales (capability, opportunity, and motivation), administered one month after the prevention activity, and will distinguish between the adoption of new habits and the abandonment of existing ones.

Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Narrowing of the carotid artery due to atherosclerosis with an unstable plaque can cause a stroke. Patients with carotid artery disease who have had a TIA or minor stroke and are at high risk of another stroke are often treated with surgery or stenting to remove the plaque. For lower-risk patients, medication alone is the better option, as surgery also carries risks. A new decision method, based on MRI detection of unstable plaques (IMPROVE), can better assess stroke risk and help determine which patients do or do not need surgery. We are investigating whether this method is at least as effective as the standard approach, which mainly considers the degree of narrowing. We expect that this new method will help reduce strokes and lower healthcare costs. Patients will be followed for several years to compare which method is better for health and costs.

A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease

The goal of this clinical trial is to learn if Yiyang Huoluo Decoction (a custom Chinese herbal medicine) works safely and effectively to treat coronary heart disease with atherosclerosis in older adults. It also aims to find out how this herbal treatment may affect blood vessel health and repair at a cellular level. The main questions it aims to answer are: * Does adding Yiyang Huoluo Decoction to standard Western medical care improve symptoms and heart-related health in older adults with coronary heart disease and atherosclerosis? * Is Yiyang Huoluo Decoction safe for older adults to take alongside their regular heart medications? * How does this herbal treatment affect the damaged blood vessels in study participants? Researchers will compare two groups of participants to see if the combined treatment works better than standard care alone. Who can take part: Older adults diagnosed with coronary heart disease and atherosclerosis who meet the study's health and eligibility rules. What participants will do: * Be split randomly into two groups of 15 people each: one group gets standard Western heart medicine only, and the other gets standard Western heart medicine plus Yiyang Huoluo Decoction (herbal granules) * Complete the 12-week decoction treatment plan as directed by the research team * Attend scheduled study visits for health checks, blood tests, heart and blood vessel scans (such as carotid ultrasound and coronary CTA), and symptom reviews * Provide two small blood samples for research testing (samples will be destroyed after study testing is finished) * Report any side effects, discomfort, or changes in health to the research team right away All personal health information collected for this study will be kept private and confidential. Participation is completely voluntary, and participants may quit the study at any time for any reason without losing access to regular medical care.

TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category. Material and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day and/or rosuvastatin to 40 mg/day will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months. Results. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function. Conclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.

Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques

The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries). The main questions the study aims to answer are: * Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone? * Is this treatment safe for patients? Participants will: * Undergo imaging of their coronary arteries during their planned heart procedure (PCI) * Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment * Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure. * Undergo a second heart catherization 9 months later to examine changes in the plaque.

Exploring Sustainable Alternatives to Marine Oils With Echium and Ahiflower Oils

This randomized, single-blind, crossover clinical trial aims to evaluate Echium oil and Ahiflower® oil as sustainable, plant-based alternatives to marine oils for omega-3 supplementation. Although fish oil is the primary dietary source of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), its use as a dietary supplementation presents several drawbacks, including high cost, potential contamination, limited global supply, and sustainability concerns. Echium and Ahiflower oils are naturally rich in stearidonic acid (SDA), a metabolic intermediate that bypasses the rate-limiting Δ6-desaturase step in the omega-3 pathway, potentially enhancing the conversion to EPA. Fifteen participants will undergo three 8-week intervention phases-Echium oil (15 g/day), Ahiflower oil (15 g/day), or EPA capsules (2.34 g/day)-separated by four-week washout periods. Blood samples will be collected before and after each phase to measure fatty acid profiles in plasma, plasma fractions, and erythrocytes using GC-MS. Anthropometric and biochemical parameters will also be assessed. The study seeks to determine whether SDA-rich plant oils can effectively increase EPA levels in humans and potentially reduce the reliance on marine oils for cardiovascular health benefits.

A Cohort Study on Cardiovascular and Cerebrovascular Outcomes

A standardized tool for grading carotid atherosclerotic plaques-dubbed Carotid Plaque-RADS (Reporting and Data System)-has recently been developed. Ultrasound (US) is one of the most frequently utilized methods in carotid screening worldwide. However, the clinical utility of US-based carotid plaque-RADS in refining stroke risk stratification beyond conventional stenosis grading has not been thoroughly validated. This study intends to conduct a bidirectional cohort study. In the retrospective part, we will collect relevant clinical data of patients and combine the Plaque-RADS scoring system to establish a risk regression prediction model for cardiovascular and cerebrovascular events in patients with carotid plaques. We will also prospectively collect a batch of patient data and incorporate ultrasound vector flow imaging and vascular hardness analysis to conduct a prospective cohort study, and further verify the accuracy and effectiveness of the model. Through this research, we aim to identify high-risk patients early, provide early intervention and treatment for high-risk individuals, and reduce the mortality and disability rates of cardiovascular and cerebrovascular diseases.