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Atherosclerosis clinical trials

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NCT ID: NCT01642173 Completed - Clinical trials for Endothelial Dysfunction

Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The investigator's hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

NCT ID: NCT01640613 Completed - Clinical trials for Regional Anesthesia Morbidity

Anterior Ultrasound-guided Cervical Plexus Block for Carotid Endarterectomy

Start date: April 2012
Phase: N/A
Study type: Observational

The aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy. The investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.

NCT ID: NCT01634906 Completed - Atherosclerosis Clinical Trials

Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

EBABAST
Start date: July 2012
Phase: N/A
Study type: Interventional

Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB. Objective: to investigate the effect of statins on ery-apoB levels. Study design: a non-randomized intervention study. Ery-apoB will be measured twice in volunteers who are on statin therapy for medical reasons. After a baseline measurement of ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a second measurement of ery-apoB. Consecutively subjects will start with their original statin therapy again. Study population: patients on statin therapy aged 18 years or older. Intervention: temporary discontinuation of statin therapy for a period of six weeks. Main study endpoints: changes in ery-apoB levels. Risks, burden and benefits on participation: volunteers will visit the outpatient clinic twice, the second visit will be exactly six weeks after the first visit. The volunteers' general practitioner and medical specialist (internist or cardiologist) will be informed about their participation. Subjects have to fast for 10 hours before every visit and venous blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will discontinue their usual statin therapy for a period of six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.

NCT ID: NCT01630200 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease and Allied Conditions

Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)

ELASTIC
Start date: May 2012
Phase: Phase 4
Study type: Interventional

Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis. Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data. The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.

NCT ID: NCT01604213 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease

VAAST
Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate that combined vildagliptin-metformin therapy is associated with clinically significant reductions in biological markers of inflammation, pro-thrombogenicity, and atherosclerosis as compared to metformin mono-therapy in a population of diabetic patients with coronary artery disease who undergo cardiac rehabilitation. The pre-specified established biological markers of inflammation, pro-thrombogenicity, and atherosclerosis will include: interleukin-6 (IL-6 - primary biological marker), hs-CRP, platelet reactivity testing, MMP-9, Interleukin 1 beta (IL-1 beta) and adiponectin levels.

NCT ID: NCT01600690 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of 5-day Statin Withdrawal on Endothelial Progenitor Cells and Inflammatory Markers in Type 2 Diabetic Patients

SStatin-EPC
Start date: May 2012
Phase: Phase 4
Study type: Interventional

Statins are commonly prescribed to lower cardiovascular risk in primary and secondary prevention. Despite their well known efficacy, statin withdrawal is a common event. Even a short term statin withdrawal can have dramatic consequences on atherosclerotic plaque stability, owing to a rebound in cholesterol levels and inflammation. The effects of a short term statin withdrawal on endothelial progenitor cells (EPC) and monocyte/macrophage polarization is unknown. In this study, the investigators will explore the effects of a 5-day statin withdrawal on EPC and monocyte/macrophage polarization, together with other inflammatory biomarkers in type 2 diabetic patients. The investigators hypothesize that statin withdrawal determines a reduction in EPC levels and an inflammatory cell polarization. Patients will be randomized to continue their habitual statin regimen or to withdraw statin. At baseline and 5 days later, blood samples will be collected for experimental measures.

NCT ID: NCT01598948 Completed - Atherosclerosis Clinical Trials

Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis

MICA
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of disease. In most patients life style modification together with lipid lowering drug therapy is sufficient to achieve this goal. In some patients with severe forms of hypercholesterolemia, this may not be sufficient to reach goals and regular lipid apheresis (a costly and time intensive form of therapy) may be performed. Mipomersen is a new drug (apoB antisense oligonucleotide) that can lower LDL-cholesterol even in the most severe forms of LDL-hypercholesterolemia by 25-47%. It is unknown whether and to what extent mipomersen can decrease LDL-cholesterol in patients treated with regular apheresis. Phase 1 of the study will test how 6 months of weekly therapy with mipomersen affects LDL-cholesterol in patients with severe LDL-hypercholesterolemia treated with regular apheresis. Phase 2 will test in how many patients this will result in a meaningful reduction of apheresis time, apheresis frequency or if apheresis can be stopped completely.

NCT ID: NCT01594710 Completed - Clinical trials for Metabolic Syndrome, Atherosclerosis

Risk Factor Analysis for Developing Metabolic Syndrome in Korean Adults

Start date: February 2012
Phase: N/A
Study type: Observational

In Asia, the prevalence of metabolic syndrome have been dramatically increased. Therefore, the investigators intend to the collect the blood sample, laboratory, anthropometric, and body composition parameters prospectively to examine the risk factors of metabolic syndrome. Furthermore, the investigators will collect the data of carotid IMT and branchial ankle pulse wave velocity to clarify the metabolic risk factors of atherosclerosis.

NCT ID: NCT01589224 Completed - Metabolic Syndrome Clinical Trials

Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT

Start date: May 2012
Phase: N/A
Study type: Observational

Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality for the coronary artery disease. Recently, novel adipokines and hepatokines as well as various inflammatory markers have been known as direct regulators of atherosclerosis. Therefore, the investigators examine the correlation of various metabolic risk factors including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT in apparently healthy people.

NCT ID: NCT01587365 Completed - Atherosclerosis Clinical Trials

Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins

Start date: May 2012
Phase: Phase 1
Study type: Interventional

To obtain safety and tolerability information in healthy subjects is administered as a single dose