300,000+ clinical trials. Find the right one.

113 active trials for Atherosclerosis

LipiScan- Ultrasound INterrogation of Atherosclerotic Coronary Arteries:

The goal of this study is to correlate both plaque and % lipid core content assessed by NIRS-IVUS (Imaging technique) to plaque burden and % lipid core content in coronary computerized tomographic angiography (CCTA) completed at 1 week in non-culprit coronary arteries.

Start: April 2016

The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin?Comparing With Standardized Statin

Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of similar lipid-lowering efficacy while was associated with less fatigue than statins. The purpose of this study is to evaluate the efficacy and safety of combined therapy with red yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular disease and who qualified for statin therapy according to national guidelines.

Start: November 2015

Computed Tomography Coronary Angiography (CTCA) Prognostic Registry for Coronary Artery Disease

The study aims at pooling a large population of patients with suspected coronary artery disease (CAD) who underwent Computed Tomography Coronary Angiography (CTCA) and who were adequately stratified in the first place. Then the investigators will be able to assess the incremental value of CTCA in the stratification of prevalence of disease (non obstructive/obstructive) and prognosis of patients with suspected CAD). The added information to current evidence is how reliable and to what extent CTCA can define the actual burden of disease and cardiovascular risk.

Start: September 2010

Mediators of Atherosclerosis in South Asians Living in America

South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.

Start: September 2010

Machine Learning for Handheld Vascular Studies

The use of handheld arterial 'stethoscopes' (continuous wave Doppler devices) are ubiquitous in clinical practice. However, most users have received no formal training in their use or the interpretation of the returned data. This leads to delays in diagnosis and errors in diagnosis. The investigators intend to create a novel machine-learning algorithm to assist clinicians in the use of this data. This study will allow the investigators to collect sound files from the use of the devices and compare the algorithms output to established, existing vascular testing. There will be no invasive procedures, and use of these stethoscopes is part of routine clinical care. If successful, this data and algorithm will be later deployed via smartphone app for point of case testing in a separate study

Start: September 2016

RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA). Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Start: March 2017

A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

Start: December 2016

Disease Prevention in Clinical Practice Base on Patient Specific Physiology

It is well known that the Type 2 diabetes and vascular disease are preceded by over ten years by metabolic dysfunction and anatomic changes that can be quantified. In order to develop effective preventive strategies and reduce the cost burden to the health care system, recognition of the earliest pathophysiology of Type 2 diabetes and vascular disease is clinically relevant. The interval retrospective evaluation of data from patient records, reflect the effectiveness of the various treatments implemented in clinical practice. Prevalence of "prediabetes" among American adults is estimated to be ~84 million, or one out of three Americans. Over a 5-7 year period approximately one third of these prediabetic individuals will progress to type 2 diabetes. Prediabetes is a heterogenous group comprised of individuals with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and increased A1c (5.7-6.4%). Although different pathophysiologies are present in individuals with IFG and IGT, their conversion rate to overt type 2 diabetes mellitus (T2DM) is similar. Insulin resistance is a common causal feature of many of the pathophysiologic mechanisms linking macrovascular disease and type 2 diabetes. Because hyperglycemia is the major factor responsible for the development of microvascular complications, it logically follows that prevention of progression of prediabetes to overt diabetes should retard/prevent the development of the microvascular complications. From the measurement of plasma glucose, insulin, and c-peptide levels during the oral glucose tolerance test, one can derive measures of the two core defects responsible for the development of T2DM, i.e. insulin resistance and beta cell dysfunction as well as the degree of dysglycemia. By combining a standard medical evaluation with the evaluation of cardiovascular biomarkers, patients at intermediate risk of vascular disease can be identified. In these patients, carotid intima media thickness (IMT) and carotid plaque evaluation is offered to attempt to clarify risk. The hypothesis of this observational study is that the characterization of the physiology and anatomy of patients at risk of developing type 2 diabetes and/or cardiovascular disease can stratify risk of developing disease and direct treatment strategies tailored to the identified physiologic defect, leading to improvements in the delay or prevention of disease.

Start: January 2009

The Microbiome as a Target for Precision Medicine in Atherosclerosis

Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular disease. Classic studies have confirmed well-established etiopathogenic factors of atherosclerosis based on genetic and immunological components and environmental modifying agents such as diet and exercise. But in addition, recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be an additional factor that participates in the onset and progression of atherosclerosis. The objective of this study is to identify the potential interactions between changes in the microbiota, changes in the immune status, the clinical evolution and the instability and progression of atherosclerosis.

Start: February 2018

COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM)

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.

Start: June 2003

Anti-inflammatory Effects of Simvastatin

The purpose of this research study is to determine which of the two ingredients of Vytorin (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin

Start: May 2017

Treatment of Patients With Atherosclerotic Disease With Methotrexate-associated to LDL Like Nanoparticles

The investigators propose a prospective, randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the safety and efficacy of an anti-inflammatory agent methotrexate in a cholesterol-rich non-protein nanoparticle (MTX-LDE) in patients with stable coronary disease. Patients with multi-vessels stable coronary disease will be randomized to receive MTX-LDE IV or placebo-LDE IV each 7 days for 12 weeks. The primary and main secondary endpoints will be analyzed by coronary and aortic CT angiography, that will be performed before the first treatment cycle, four weeks after the last drug infusion and 12 months after randomization. Patients will undergo clinical and laboratory safety evaluations before each treatment cycle, four weeks after the last cycle and 12 months after randomization. An algorithm for drug suspension based on clinical and laboratory finding will be followed.

Start: October 2020

SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients at One Month

The purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding (HBR).

Start: November 2018

Rosuvastatin Effect on Atherosclerotic Plaque Metabolism

Atherosclerotic plaque uptake of 18F-sodium fluoride (NaF) in positron emission tomography with computed tomography (PET-CT) was recently shown to correlate with clinical instability in patients with CV disease. We hypothesize that rosuvastatin reduces 18F-NaF plaque uptake. Our group will scan coronary, aortic and carotid arteries of high-risk CV subjects with 18F- NaF-PET-CT. Individuals with 18F-NaF-positive plaques will be treated with rosuvastatin for six months, followed by 18F-NaF-PET-CT re-evaluation.

Start: July 2020

Ischemic Strokes While on NOAC - How Compliance Matters

This study is aimed to depict the epidemiological trend, aetiologies, clinical characteristics, treatment options of IS-NOAC in face of the rapidly increasing NOAC usage. Knowledge on this ischaemic stroke entity will define clinical characteristics, identify preventable causes and inform resource allocation on the evaluation modalities, reperfusion strategies and forecast future burden of IS-NOAC.

Start: October 2020

Treatment of Patients With Atherosclerotic Disease With Paclitaxel-associated to LDL Like Nanoparticles

The investigators propose a prospective, randomized, double-blind, placebo-controlled study. The purpose of the study is to evaluate the safety and efficacy of an anti-proliferative agent paclitaxel in a cholesterol-rich non-protein nanoparticle (Paclitaxel -LDE) in patients with stable coronary disease. Patients with multi-vessels stable coronary disease will be randomized to receive Paclitaxel-LDE IV or placebo-LDE IV each 21 days for 6 weeks. The primary and main secondary endpoints will be analyzed by coronary and aortic CTA, that will be performed 1-4 weeks after randomization and at 3-8 weeks after the last treatment cycle. Patients will undergo clinical and laboratory safety evaluations before each treatment cycle and 3-8 weeks after the last cycle. An algorithm for drug suspension based on clinical and laboratory finding will be followed.

Start: June 2019

IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective.

Start: October 2020

Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D

A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee.

Start: November 2020

Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.

Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm). This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint: -The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency). Secondary endpoints: Clinical efficacy of the method of surgical treatment after 24 months (MALE); Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE); Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire); Evaluation of prognostic factors for adverse outcomes after surgical treatment.

Start: October 2020

Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection

This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry. To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia. The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inflammation in the body.

Start: July 2003