Clinical Research Directory

DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT

Atherosclerosis is preventable, yet it continues to significantly contribute to global morbidity and mortality. Atherosclerosis may occur early in life and may present in all vascular territories. The DETECT study's main aim is to determine the prevalence of asymptomatic atherosclerosis (silent) in an adult population of a wide age range of European ancestry through vascular ultrasound (VUS) of peripheral arteries (carotid and femoral territories), as well as establishing the relationship between atherosclerosis in peripheral arteries, coronary arteries, and other vascular territories assessed by computed tomography angiography (CTA). The DETECT study also aims to identify risk factors for development of subclinical atherosclerosis that can hopefully improve the detection of the risk for development of atherosclerotic cardiovascular disease (ASCVD) with far higher precision than currently. In future research, the findings in this descriptive study may eventually be used as part of an age-adapted imaging-based screening for subclinical atherosclerosis. The investigators hypothesize that a precision medicine-based approach to identify candidates likely to benefit from primary prevention against atherosclerosis, may improve medical decision making, by combining traditional risk factors, including lifestyle and psychological factors, phenotypic findings and findings on vascular imaging, and patterns of circulating biomarkers to identify risk of atherosclerosis especially in young individuals and at earlier disease stages (the ultimate population target of REACT project, phase II), maximizing the potential for prevention long before overt disease occurs. An essential aspect of this approach is to pinpoint the specific risk factors in each individual that primarily drive atherosclerosis throughout their life and could serve as therapeutic targets. Thus, the overall purpose of this study is to establish the necessary knowledge, including extensive characterisation of atherosclerosis across life and thus add to the rational foundation for future development of a far more efficient and precise prophylaxis against ASCVD as compared with the presently applied methods.

AI-THEROSCOPE: AI Detection of Subclinical Atherosclerosis From Retinal Images

Cardiovascular risk scores are widely used for risk stratification but may fail to identify a substantial proportion of individuals with subclinical atherosclerosis who are at increased risk of future cardiovascular events. Vascular ultrasound can directly detect carotid and femoral atherosclerotic plaques but its implementation is limited by the need for trained operators and expert interpretation. The AI-THEROSCOPE study aims to develop and validate an artificial intelligence-based tool capable of detecting subclinical atherosclerosis through the analysis of non-mydriatic retinal fundus images. Participants undergo clinical assessment, laboratory testing, carotid and femoral ultrasound, and retinal fundus photography. The performance of the AI model will be evaluated against vascular ultrasound findings as the reference standard for the presence of subclinical atherosclerosis.

Adipose Visceral and Epicardial Risk Evaluation

The goal of this procedure-based interventional study without drugs or devices is to investigate the molecular mechanisms underlying metabolically unfavorable obesity and related clinical phenotypes, in order to identify non-invasive biomarkers capable of early prediction of metabolic syndrome, type 2 diabetes mellitus, MASLD, and cardiovascular disease in adult participants without known cardiovascular or liver disease. The main questions it aims to answer are: * What is the association between epicardial and visceral fat thickness and plasma levels of low-grade inflammatory biomarkers? * How do these parameters relate to the presence of metabolic syndrome, type 2 diabetes mellitus, MASLD, and subclinical atherosclerosis? Participants will: * Undergo a comprehensive clinical evaluation, including demographic, anthropometric, and medical history data; * Complete non-invasive diagnostic assessments, including 12-lead electrocardiogram, transthoracic echocardiography, liver elastography (FibroScan), and carotid Doppler ultrasound; * Provide peripheral venous blood samples for biochemical, cellular, and molecular analyses.

Guideline Adherence in Dyslipidemia With Clinical Decision Support

Objective: To validate the performance of the developed clinical decision support system (CDSS) for participants with lipid metabolism disorders based on a decision tree algorithm. Materials and Methods: A clinical decision support system for participants with lipid profile abnormalities will be developed using the Orbeon open-source online form creation platform based on current clinical guidelines. During the CDSS pilot implementation, the electronic medical records (EMRs) of 500 participants from the Institute of Personalized Cardiology of the Biomedical Science and Technology Park at Sechenov University will be analyzed. Retrospective data on prescribed lipid-lowering therapy extracted from the EHR will be compared with the CDSS recommendations. The accuracy of the decisions will be assessed by three independent experts based on digitized clinical and laboratory patient profiles. The primary endpoint of the study will be to determine the accuracy of the system. Results: This study will result in the development (creation) and pilot application of the CDSS program in participants with dyslipidemia in real clinical practice. Conclusion: The developed CDSS system for dyslipidemia will significantly reduce the time required for clinical decision-making and help avoid errors in the interpretation of patient data.