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113 active trials for Atherosclerosis

A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults

MITIGATE is a prospective, open-label, parallel-group, randomized, pragmatic clinical trial. The MITIGATE Study has been designed to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), also known as Vascepa®, compared to usual standard of care to prevent and reduce the sequelae of laboratory-confirmed viral upper respiratory infection (URI)-related (i.e., COVID-19, influenza, and other known viral respiratory pathogens) morbidity and mortality in a high-risk cohort of adults with established atherosclerotic cardiovascular disease (ASCVD).

Start: August 2020

11C-PIB PET Study in MESA at Columbia University

The investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Participants will be imaged only once with Pittsburgh Compound B (PIB) PET.

Start: August 2020

ABLUMINUS DES BTK Registry - FIM

A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.

Start: August 2020

A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study

The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.

Start: March 2021

Coronary Artery Disease Progression in Patients With Prediabetes

Prediabetes is a disorder of glucose metabolism that reflects the natural history of progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent restenosis after bare metal and drug-eluting stent implantation more frequently is observed in patients with high fasting-insulin levels and IR. Although IR has a significant role in the progression of atherosclerosis in prediabetic patients, the importance of managing prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment has been officially approved for prediabetes. According to American Diabetes Association recommendations, metformin is the only drug that could be considered in the treatment of prediabetic patients with a high risk of developing diabetes. Metformin is a safe and inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events in patients with type 2 diabetes as well as the progression of atherosclerosis in non-diabetic animal models. This study was designed to analyze coronary plaque characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic patients at 24 month follow up. The study hypothesis is that more pronounced coronary atherosclerosis progression as well as in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin treatment attenuates the progression of atherosclerosis in patients with prediabetes.

Start: February 2016

CCTA, CACS and ECG Stress Testing in Patients With Suspected CAD: Precision Phenotyping and Financial Evaluation

The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms describes in brief the main objective of this protocol. The design of the present proposal is based on current state-of-the-art literature, incorporating, however, additional innovative elements. It is about the first randomized study to be conducted in Greece, investigating the role of CCTA and CACS in CAD diagnosis and risk assessment. Moreover, the present protocol aims to integrate information on patients' metabolomic profiling. The process of the whole information by using artificial intelligence technology will lead to the development of new risk stratification algorithms, promoting further personalized diagnostic and therapeutic approach. Regarding Greece, this is the first prospectively enrolling medical database of this scale.

Start: January 2021

CHOCO-CABANA Trial

The study will be performed 120 patients at about 6 to 8 study centers. Only patients with clinical conditions requiring assessment of patency of the treated BTK lesions at 6 months post procedure by MRA as part of standard care to prevent amputations as consequence of non-detected re-stenosis/occlusions will be included in the study. The sequence in which the individual patients will be treated will be randomized with the Chocolate PTA balloon and the uncoated conventional PTA balloon at each center. 60 patients will be randomized to uncoated conventional PTA balloon treatment and 60 patients to treatment with the Chocolate PTA balloon. All lesions in each patient (lesions that fulfill the inclusion/exclusion criteria) should be treated as the patient is randomized. In patients with long lesions more than one balloon may be used. Overlapping of balloons (at least 10mm) is mandatory to avoid untreated gaps between sequential treatments. Follow up will be performed at 1 and 6 months.

Start: August 2020

Efficacy of Subintimal vs Intraluminal Approach for Atherosclerotic Chronic Occlusive Femoropopliteal Arterial Disease

There are two ways of approaching atherosclerotic chronic occlusive femoro-popliteal arterial lesion with guide wire. One is the intraluminal approach of passing guide wire through the atheroma, the other is the subintimal approach of passing wire through the subintima of the vessel. Either of these two interventional technique can be chosen depending on the character of the lesions they have their own pros and cons which affects the success of the intervention. The study is limited to retrospective studies to which interventional technique is better for post-procedural recurrence rate, however there is no prospective randomized controlled study.

Start: May 2014

Apoptosis Proteins and Endothelial Dysfunction in Patients With Atherosclerosis of Peripheral Arteries

Modern vascular surgery has various options for open and endovascular surgical methods aimed at treating patients with peripheral arterial diseases. Despite the achievements of vascular surgery, the occurrence of postoperative complications levels out the success of surgical interventions and requires repeated surgical interventions. The most common complication is stenosis of the reconstruction zone, which develops in approximately 50% of operated patients. At present, the apoptosis system plays an equally important role in the development of restenosis of the intervention zone. It has been recognized as a central component in the pathogenesis of atherosclerosis, in which the Bcl-2 family of proteins is activated. It is a group of cellular proteins that are important regulators of the apoptosis system in cells located in the mitochondrial membrane. In experimental animal models, it was shown that apoptosis after angioplasty of the coronary arteries proceeds in the form of two waves. After injury to the vascular wall, during the first hours, it is activated in the MMC media, and after two weeks in the cells of the neointima, by the 28th day it almost completely stops. A decrease in the apoptosis index in the postoperative period may cause the development of restenosis of the reconstruction zone. The use of antioxidants, for example, alpha-tocopherol acetate, in the first month of the postoperative period, at the time of activation of apoptosis, inhibits the latter and reduces the proliferative activity of the SMC media and neointima. One month after surgery, delayed apoptosis of vascular wall cells can lead to the development of neointima and restenosis. In this case, the use of drugs that enhance apoptosis, for example, lipophilic statins, calcium channel blockers, will be relevant. Nitric oxide metabolites, depending on the concentration, can act as both an inducer and an inhibitor of apoptosis. The mechanism of NO-induced apoptosis in SMC includes an increase in the Bax / Bcl-2 expression ratio, which leads to the release of cytochrome C from mitochondria, activation of caspase-3 and -9. In patients with atherosclerosis of the peripheral arteries, proteins of the Bcl-2 family and their relationship with markers of endothelial dysfunction have not been sufficiently studied, the results obtained are contradictory.

Start: January 2020

Evaluation of Asymptomatic Coronary Atherosclerotic Disease Among People of Kalamazoo, MI

The primary goal of this study is to determine the prevalence of undiagnosed asymptomatic coronary artery disease (CAD) in Kalamazoo and its neighboring areas using Coronary Computed Tomography (CCTA) and Coronary Artery Calcium Score (CACS) to assess if asymptomatic CAD is widespread enough to warrant implementation of CCTA as a routine screening tool. Additionally, this study will use the CCTA results to evaluate several methods of assessing CAD risk in the asymptomatic population including Framingham Risk Score (FRS) and Reynold's Risk Score, Biomarkers (High sensitivity C-Reactive Protein, Fibrinogen, Vertical Auto Profile, oxidized Low Density Lipoprotein (LDL), Apolipoprotein A1 (ApoA1), Apolipoprotein B1 (ApoB1), Vitamin D, Homocysteine) as well as a large panel of genetic markers of atherosclerosis and dyslipidemia.

Start: March 2016

Clinical Transfer of a Vulnerable Atherosclerotic Plaque Tracer : 99mTc-cAbVCAM1-5 (ATHENA)

Clinical Transfer of a Tracer of the Vulnerable Atheroma Plate: 99mTc-cAbVCAM1-5. (ATHENA). This is a phase I/IIa, prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

Start: September 2020

The Effect of Coffee Consumption on the Serum Levels of Leptin, Folic Acid, and Vitamin B12

The effect of coffee and body weight during the last 3 months on the level of leptin, folic acid, and vitamin B12

Start: July 2020

Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment

Cardiovascular disease (CVD) remains the leading cause of death in the United States, and improved CVD risk assessment is needed for personalized medicine. Atherosclerosis measures including plaque volume and adverse plaque features have prognostic value. Novel techniques have been developed for assessing carotid, coronary, and femoral atherosclerosis using magnetic resonance imaging (MRI) methods that are rapid and reproducible, have improved spatial resolution, and do not require contrast media, making atherosclerosis assessment in multiple vascular beds feasible during a single MRI session. This pilot research will provide preliminary data to develop an innovative global atherosclerosis measure including carotid, coronary, and femoral vascular beds, for assessing cardiovascular risk and for monitoring atherosclerosis response to therapy. 20 participants will be recruited in one year.

Start: September 2014

Pilot Study Evaluating the Impact of Stress Reduction on Atherosclerotic : Heart and Mind Study

The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial stress.

Start: September 2018

The Physical Activity and Nutrition in Children (PANIC) Study

The Physical Activity and Nutrition in Children (PANIC) Study is a single-centre controlled trial on the effects of a combined physical activity and dietary intervention on cardiometabolic risk factors and other health outcomes in a population sample of children from the city of Kuopio, Finland. The study provides novel scientific information for the identification of cardiometabolic diseases and other chronic diseases since fetal period and for the prevention of these chronic diseases since childhood. The main hypothesis of the PANIC study is that individuals at increased risk of cardiometabolic diseases and other chronic diseases can be identified in childhood and that it is possible to start the prevention of these chronic diseases by a long-term physical activity and dietary intervention since childhood.

Start: October 2007

Characterization of Novel Lipoprotein Properties Associated With an Increased Risk to Develop Atherosclerosis

Objectives of Medical Research: Separation of LDL and HDL from blood samples of patients with high LDL and / or low HDL who have developed atherosclerotic disease with similar patients who have no evidence of atherosclerosis. Lipidomics and proteomics will examine whether there is a difference in lipid and protein composition and lipoprotein composition. If there are any changes in expression level or the composition of proteins or metabolites that make up lipoproteins, we will try to figure out the mechanism responsible for these changes and their role in the metabolic process. we will seek therapeutic measures through which these mechanisms can be inhibited and thus inhibit the development of sclerosis or even retraction.

Start: April 2020

ILUMIEN IV: OPTIMAL PCI

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

Start: March 2018

Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery

The purpose of this study is to determine if evolocumab added to regular statin therapy improves vein graft patency after coronary artery bypass graft (CABG) surgery.

Start: May 2019

Biomarkers of Acute Stroke in Clinic

The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below: Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out, as defined by TOAST classification of subtypes of acute ischemic stroke. Aim 2: In cases of ischemic strokes of unknown or "cryptogenic" etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic.

Start: September 2019

Multiomics and Imaging-based Assessment of Vulnerable Coronary Plaques in Acute Coronary Syndromes

The aim of Multiplaque clinical study is to assess the vulnerability degree of the atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics analysis, associated with invasive and non-invasive data. In this study, a multi-parametric model for risk prediction will be developed, for evaluation of the risk that is associated with the vulnerable coronary plaques in patients that have suffered an acute coronary syndrome. In the study, evaluation of the imaging characteristics of these coronary plaques will be performed with the use of CT, OCT, IVUS and invasive angiography. We will study the correlation between plaque evolution and (1) the degree of vulnerability at baseline, (2) multiomics profile of the patients and (3) clinical evolution during follow-up. Also, new techniques for evaluation of the functional significance of coronary stenoses will be studied and validated, such as calculation of the fractional flow reserve or determination of shear stress in areas that are localized within the near vicinity of the vulnerable coronary plaques.

Start: April 2018