Clinical Research Directory

Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome

The goal of this clinical trial is to evaluate whether triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) is more effective than dual therapy (atorvastatin and ezetimibe) in reducing LDL cholesterol levels in adults with acute coronary syndrome. It will also assess the safety of the treatment. The main questions it aims to answer are: * Does triple therapy result in greater reduction in LDL-C compared to dual therapy? * What adverse effects occur in participants receiving triple therapy? Researchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels. Participants will: * Receive either dual or triple lipid-lowering therapy for 3 months * Attend regular follow-up visits for clinical assessment and laboratory testing * Undergo lipid profile evaluation at baseline and at the end of the study

Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile

The goal of this clinical trial is to assess the effects of corn and avocado oils as part of controlled feeding diets on the cardiometabolic risk factor profile in men and women with mild-to-moderately elevated levels of non-high-density lipoprotein cholesterol (non-HDL-C). Participants will be asked to consume the controlled feeding diet for two separate 21 day conditions, and will consume their regular diet for a 21 day washout period between the two conditions. Additionally, participants will be asked to come into the clinic on 7 different occasions, including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 21-d diet condition (visits 3 \& 6, day 19 and visits 4 \& 7, day 21), and a visit at the conclusion of the washout phase/start of the second diet condition (visit 5, day 0).

Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease

LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy.

Causes and Natural History of Dyslipidemias

This study will evaluate people with dyslipidemias - disorders that affect the fat content in the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood in particles called lipoproteins. These particles are involved in causing blood vessel diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or heart attack. Participants will undergo accepted medical tests and procedures to evaluate their condition. Most of the test results are helpful in making a diagnosis and in guiding treatment. People with lipid disorders are eligible for this study. Representative types of patients include those with: * Plasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl * Plasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl * Plasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl * Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin) Children under 2 years of age are excluded from the study. Participants will undergo some or all of the following procedures: \- Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes involved in lipid metabolism are measured....

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia

The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic acid and/or its fixed-dose combination with ezetimibe in managing plasma levels of low-density lipoprotein cholesterol (LDL-C). Secondary objectives are to document and evaluate as applicable: * Assessment of the cardiovascular risk of patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe using different risk scores (e.g. Systematic Coronary Risk Estimation (SCORE) system, SMART score for Very High Risk patients and Framingham risk score for High Risk patients. The scores will be re-calculated during the analysis and used as an analytical tool only). * Changes in low-density lipoprotein cholesterol (LDL-C) levels prior to treatment with bempedoic acid and/or its fixed-dose combination with ezetimibe compared to 1 year follow-up and subsequent data collection points, if applicable. * Characterize plasma levels of other potentially ASCVD-modifying cholesterol fragments, namely, LDL-C, total cholesterol (TC), apolipoprotein B (apoB), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, triglycerides (TGs) and lipoprotein A (Lp\[a\]) compared to 1 year follow-up and subsequent data collection points, if applicable. * Changes in the levels of inflammatory marker hsCRP compared to 1 year follow-up and subsequent data collection points, if applicable. * Adverse Drug Reactions associated to bempedoic acid and/or its fixed-dose combination with ezetimibe. * Changes in uric acid levels compared to 1 year follow-up and subsequent data collection points, if applicable. * Relevant CV events: * Myocardial infarction * Unstable angina * Coronary artery bypass graft surgery (CABG) * Percutaneous transluminal coronary angioplasty (PTCA) * Stroke * Transient ischemic attack (TIA) * Acute peripheral arterial occlusion * All-cause death * Cardiovascular (CV)-death * Adverse effects associated with lipid-modifying treatment (LMT) * Laboratory abnormalities * Muscle-associated symptoms * New onset and/or worsening diabetes * Changes in the patients´ glycemic status over time * Site characteristics (sites and practitioners) caring for patients treated with bempedoic acid and/or its fixed-dose combination with ezetimibe. * Use of LMTs prior or concomitantly to receiving bempedoic acid and/or its fixed-dose combination with ezetimibe (therapies including combination treatments). * Bempedoic acid and/or its fixed-dose combination with ezetimibe treatment parameters such as treatment duration by therapy, dosage, prescription intervals, permanent discontinuations, switches and reasons for these, (concomitant medication, additional therapy/interventions). * Healthcare resource use especially consultation visits with specialist, nurse time and hospitalizations as well as patient-reported outcome using EQ-5D-5L and PAM-13.

A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Elevated Lipoprotein(a) in Hospital Staff

The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population.

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels). The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug once a week * How much study drug is in the blood at different times

Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial

The goal of this clinical trial is to learn whether simple electronic information letters can increase patient activation and improve risk-factor monitoring in adults in Denmark with ischemic heart disease (IHD) who have LDL cholesterol above the recommended treatment target. A subgroup of participants with elevated lipoprotein(a) \[Lp(a)\] will also be randomized to receive an additional information letter. The main questions the study aims to answer are: * Does sending an electronic letter about elevated LDL cholesterol increase the proportion of patients who have at least one LDL-cholesterol test within 6 months? * Among patients with ischemic heart disease and elevated Lp(a), does receiving an information letter about Lp(a) increase patient activation, reflected by cardiometabolic risk-factor monitoring? Because this is a randomized trial, researchers will compare people who receive the electronic letter(s) with people who do not receive any letter to determine whether the letters encourage patients to take action, such as obtaining laboratory tests or contacting their doctor. Participants will: * Receive an electronic letter through Denmark's national digital mailbox system (Digital Post) or receive no letter, depending on random assignment. * Continue their usual health care, with no additional visits, treatments, or procedures required for the study. * Have all study information collected from existing Danish nationwide health registries.

Vascular Intervention Strategies Trial for Alzheimer's

The proposed pharmacist-led study is a feasibility pilot trial for the management of vascular risk factors of hypertension and hypercholesterolemia in 10 APOE ε4 carriers, 50-75, at-risk for dementia. All participants will receive angiotensin receptor blockers (ARBs) for high blood pressure, and hydrophilic statins (or a non-statin alternative) for high cholesterol over a six-month period.

Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides

A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology/American Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.

Onco-primary Care Networking to Support TEAM-based Care

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

WB-EMS Effects on Cardiometabolic Risk Factors

From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Whole-body electromyostimulation (WB-EMS), a technology in which all major muscle groups are stimulated with an adjusted stimulation level, could be a time-effective and joint-friendly alternative. However, there are some contraindications to the widespread use of this technology, which are particularly common in middle-aged and elderly people. For example, high blood pressure, which affects more than half of men over the age of 50 in Germany, is considered a contraindication for WB-EMS training. However, this assessment is not very reliable; at least, acute WB-EMS application does not lead to an increase in blood pressure. In addition, there are no study results available for long-term WB-EMS application in people with high blood pressure. The present study particularly investigate whether and to what extent several weeks of WB-EMS training has an effect on resting blood pressure in people with mild blood pressure. Additionally, the effect of WB-EMS on other cardiometabolic risk factors and physical function will be addressed.

A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.

Improving Lipid Optimization Quality and Treatment Options in ASCVD

The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).

Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels

The goal of this study is to evaluate the hypolipidemic effect (reduction of Low Density Lipoprotein Cholesterol "LDL-C" values) of calcium-bicarbonate mineral water "Lete" (alkaline water, high in bicarbonate and calcium ions and low in sodium) compared to control oligomineral water "Sorgesana" on healthy volunteers

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy

Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population

Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

This research is being done to evaluate the short term and long term effects of ketogenic diets on measures of cardiovascular health. Such measures include cholesterol levels, blood pressure, weight, and thickening of the blood vessel wall over time. Adults aged 18 or older who are already on a ketogenic diet for at least 12 months or who are interested in beginning on the modified Atkins diet may join.

Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)

A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C

Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia

The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation. The secondary outcomes are to evaluate: \- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.

Activate Tennessee: A CHW-Supported Program for Patient Activation

The research project will involve community health workers (CHWs) that will help participants to better understand their medical conditions and to responsibly manage their medical needs. The project will focus on participants with the greatest medical needs and those that have many different illnesses at the same time. CHWs will help guide participants in focusing on improving their knowledge and confidence to manage their health conditions and to improve their ability to understand how the healthcare system works. This will give participants the opportunity to take charge of their illnesses and possibly improve their health conditions over time. The CHWs will work together with participants to develop a health plan focused on their specific health needs.