Clinical Research Directory

Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis

This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.

Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.

This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.

Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation and Cardiometabolic Health

The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol. The main questions it aims to answer are: 1. Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)? 2. Do these two diets have different effects on other measures of heart and metabolic health, such as blood fats, blood vessel function, and overall wellbeing? Researchers will compare people who follow the Mediterranean-style diet with those who follow the Carnivore-style diet to see which diet produces more beneficial changes in cholesterol and heart health markers. Participants will: * Attend three visits at Liverpool John Moores University for screening and data collection. * Be randomly assigned to follow either the Mediterranean or Carnivore diet for 3 weeks, matched for calories and protein. * Provide fasting blood, urine, and stool samples before and after the diet period. * Complete non-invasive cardiovascular tests to measure blood vessel and heart function. * Take part in a short interview and complete questionnaires about their experience of following the diet.

Erythrodiol in Pomace Olive Oil as a Protective Agent Against Atherosclerosis

The goal of this postprandial clinical trial is to learn whether erythrodiol, a triterpene naturally present in pomace olive oil, can modulate the cell foam formation, ine of the first steps in atherosclerosis. The main questions it aims to answer are: Is erythrodiol bioavailable in humans when administered as pomace olive oil? Does acute erythrodiol intake reduce postprandial triglyceride excursions after a high-fat meal? Does erythrodiol reduce the intake of postprandial triglyceride-rich lipoproteins by macrophages? Researchers will compare participants receiving test meals enriched with different concentrations of erythrodiol (low, medium, high) to see if the intervention leads to improved postprandial metabolic and vascular responses. Participants will: Attend the research facility after an overnight fast. Consume a high-fat test meal enriched with a different doses of erythrodiol Undergo serial postprandial assessments over several hours, including: Blood sampling for lipids, glucose, inflammatory markers, and oxidative stress biomarkers Monitoring of subjective tolerability and adverse events

Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles.

This study aims to investigate how moderate wine consumption influences circulating extracellular vesicles (EVs) in healthy adults. EVs are small particles released by cells that carry proteins, lipids, and genetic material, and play important roles in communication between cells. Participants will consume a single serving of red or white wine, and blood samples will be collected before and after consumption to study changes in the composition and function of EVs. The study will also assess how these EVs affect vascular, immune, and brain-related cells. The results are expected to improve our understanding of how moderate wine intake contributes to cardiovascular and brain health.

Oral Microbiome in Carotid Atherosclerosis

The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke. Researchers want to understand whether certain oral bacteria are linked to plaque vulnerability, meaning a higher chance that the plaque will rupture and cause a stroke. The study will include a cohort of adults scheduled for carotid endarterectomy at Semmelweis University. Participants will be enrolled in the Semmelweis University Carotid Biobank project. The main questions the study aims to answer are: Do people with more severe gum disease or tooth infection have a higher number of bacteria in their carotid plaques, and are those plaques more likely to rupture? Are the bacteria found in vulnerable plaques different from those in stable plaques? Are similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body? What participants will do: Have their oral health checked before surgery, including an exam of gum disease and tooth infections. Provide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery). Have preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility. All samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type. The study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care. Researchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability. The results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.

Evaluation of the Association Between the Effects of Generalized Stage 3 and 4 Periodontitis on Arterial Stiffness and Cardiovascular Risk: the PAROCAR Study

Periodontal diseases are chronic inflammatory conditions affecting nearly half of the adult population and are associated with systemic inflammatory responses. Recent evidence suggests a possible link between severe periodontitis and cardiovascular diseases through shared inflammatory pathways. The PAROCAR study aims to evaluate the association between generalized periodontitis (stages 3 and 4, 2017 Chicago Classification) and arterial stiffness measured by pulse wave velocity (PWV), compared to matched controls without periodontitis, adjusted for conventional cardiovascular risk factors.

Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus

People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death. This study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels. The goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.

[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease

This clinical trial aims to evaluate whether \[¹⁸F\]AlF-OC PET/MRI can characterize and quantify inflammation in carotid atherosclerotic plaques. The study will assess if tracer uptake in culprit and non-culprit carotid arteries, measured by standardized uptake values (SUV), is associated with future cerebrovascular events. Specifically, it will examine whether \[¹⁸F\]AlF-OC uptake predicts the risk of recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular complications. Participants will undergo \[¹⁸F\]AlF-OC PET/MRI and will be followed via telephone interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA.

The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.

Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial

Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning. The primary objective of this study is to examine whether statin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking statin.

Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.

Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite significant advances in prevention and treatment. Atherosclerosis, a chronic inflammatory condition, underlies ischemic events such as infarction and stroke, triggered by the instability and rupture of plaques. Current guidelines recommend drugs primarily aimed at reducing Low-Density-Lipoprotein cholesterol (LDL-C), arterial pressure, and glucose levels for atherosclerosis patients. However, there is little option of approved medications specifically targeting inflammation within the arterial plaques. Consequently, a significant proportion of patients face residual risks. On the contrary, numerous studies have highlighted the anti-inflammatory effects provided by omega-3 fatty acids (n-3 FA), specially the eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and their derived oxylipins. These molecules exhibit the ability to enhance the phenotype of macrophages, increasing their capacity for efferocytosis, thereby improving plaque stability. Icosapent ethyl (IPE) is an esterifed version of eicosapentaenoic acid (EPA) and acts as a prodrug in the body to exert its effects. Icosapent ethyl (IPE) was the first fish oil product approved by the US Food and Drug Administration (FDA) to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) in adults. Hence, the hypothesis of this study is that supplementing patients with IPE, in addition to their standard clinical treatment, will enhance macrophage functionality, thereby reducing inflammatory and oxidative stress biomarkers in comparison to a placebo. To test this hypothesis,a Randomized, Double-blind, Placebo-controlled Clinical trial will be performed, in which 294 patients under secondary prevention for CVDs will receive a 6-month supplementation of purified eicosapentaenoic acid-icosapent ethyl (4.0 g) daily or a Placebo (corn oil). Blood samples and anthropometric measurements will be taken at the beginning and end of the period. Basic clinical markers will be assessed, and monocytes will be collected and characterized. Fatty acid profiles and oxylipins will be determined through chromatography coupled with mass spectrometry. Finally, changes in biomarkers for both groups will undergo multivariate analysis to identify characteristics associated with the response to supplementation. Data from this study aims to provide support for physicians considering the prescription of bioactive compounds as a complementary therapy for atherosclerosis, with the goal of reducing residual risks and subsequently decreasing mortality resulting from cardiovascular events.

Variability in Human Fatty Acids Profiles Based on Blood Fractions and Metabolic Conditions

Fatty acids play a crucial role in various metabolic pathways, with their proportions and distributions across different cells and tissues influenced by diet and metabolism. In addition to providing energy through oxidative reactions, fatty acids serve as substrates for the synthesis of numerous molecules involved in cellular signaling processes. Therefore, quantifying fatty acids in biological samples is essential for ensuring the quality of clinical trials involving lipids and for understanding the relationship between fats and health conditions. However, the fatty acid profiles reported in clinical trials can exhibit significant heterogeneity due to both endogenous and exogenous factors, including the metabolic condition of the patients and the specific blood fraction analyzed. This variability makes difficult the comparison of results across studies. Moreover, despite the crucial role of fatty acids in immune response, most results are derived from erythrocytes, plasma, or serum, providing limited information on their variability in leukocytes. Thus, the hypothesis of this study is that metabolic conditions, characterized by fasting or postprandial states, can influence the fatty acid profile depending on the blood fraction analyzed. To evaluate this hypothesis, six healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention. Fatty acid levels will be measured using gas chromatography coupled with mass spectrometry in total plasma, phospholipids, erythrocytes, and leukocytes. The results will help estimate the variability caused by metabolic states according to the blood fraction, which is critical when conducting clinical trials in patients where fasting cannot be assured and is essential for comparing fatty acid profiles in studies involving leukocytes.