A Study With Darapladib to Collect Tolerability Information
AtherosclerosisSubjects will receive their first dose of darapladib in the clinical research unit (CRU), and the remaining 9 days of dosing will occur at home. Subjects will record any adverse events throughout the dosing period in a paper diary. Subjects will return to the CRU 10-14 days after the last dose of darapladib for a follow-up visit. The total study duration for each subject including the screening, treatment and follow-up periods will be approximately 4 weeks.
A Study to Evaluate the Effects of 3 Months Dosing With GW856553, as Assessed FDG-PET/CT Imaging...
AtherosclerosisThis study is being conducted to assess the potential anti-inflammatory effects of a 3-month treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques, as assessed by FDG-PET/CT.
Change in Plaque Characteristics With Atorvastatin
Acute Coronary SyndromeAtherosclerosis1 moreTo examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.
An Imaging Study in Patients With Atherosclerosis Taking Rilapladib or Placebo for 12 Weeks
AtherosclerosisA study in patients with atherosclerosis to assess safety, effect and PK of rilapladib vs. placebo over 12 weeks of dosing.
Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium
Coronary Artery DiseaseCoronary Arteriosclerosis2 moreThe purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. End points will be the assessment of development of mature and stable new blood vessels as well as improvement in cardiac function. This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the safety and feasibility of use of the proposed combination of autologous stem cells. Potential subjects who fulfill clinical and laboratory entry criteria at screening will undergo a process of bone marrow aspiration for preparation of the two types of bone marrow-derived stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant, patients will be have a 3 month follow-up to evaluate safety as well as functional heart improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography. Study population will include adult male and female subjects, ages 18-70, presenting with acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial infarction and will undergo coronary artery bypass grafting. Patients will be divided in two groups: the first group will enroll patients with acute myocardial infarction whom percutaneous coronary intervention restored myocardial flow after 4 hours or greater of the initiation of symptoms, the second group will enroll patients who are candidates for coronary artery bypass surgery and had a myocardial infarction in the past 12 months. Patients will receive the cell mixture by intracoronary or intramyocardial infusion, respectively. The rationale of this clinical study is based on the observation that most attempts using adult stem cells for myocardial regeneration have utilized a source of bone marrow derived progenitor cells with the potential to generate new blood vessel and thus contribute to the revascularization of the ischemic tissue. This therapy seems to be adequate but not sufficient, since it lacks a source of stem cells capable of differentiating and maturing into cardiac muscle cells, thus contributing to the recovery of local contractility. The proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at contributing cell types capable of regenerating both blood vessels and muscle tissues damaged after MI.
Rilonacept to Improve Artery Function in Patients With Atherosclerosis
Coronary Artery DiseaseAtherosclerosis2 moreThis study will determine whether an experimental drug called Rilonacept can improve artery function in patients with atherosclerosis, a disease in which fatty deposits in arteries cause the vessels to stiffen, impeding blood flow. Atherosclerosis is believed to be caused in part by inflammation. Rilonacept blocks production of a protein called CRP, which, in high levels in the blood is associated with increased inflammation. Patients with coronary artery disease who have elevated blood levels of CRP are at increased risk of heart attack, heart failure and sudden death compared with people who have lower levels of the protein. Patients 18 years of age and older with atherosclerotic coronary artery disease with a CRP level between 2 and 10 mg/L may be eligible for this study. Patients are randomly assigned to receive four doses of either Rilonacept or placebo, given at 2-week intervals as injections under the skin. In addition to treatment, patients undergo the following procedures during eight visits to the NIH Clinical Center: Visit 1 (screening visit): Medical history, measurement of vital signs (temperature, blood pressure, heart rate and breathing rate), electrocardiogram (EKG) and blood tests. Visit 2: Blood tests, chest X-ray, treadmill exercise testing, tuberculin skin test, brachial artery flow-mediated dilation. Brachial artery flow-mediated dilation is used to measure how well the brachial artery (artery inside the elbow) dilates. An ultrasound device placed just above the elbow measures the size of the brachial artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm. Visit 3: Injection of study drug. Visits 4, 5, and 6: Review of any changes in health or medical treatment, measurement of vital signs, blood tests, EKG, injection of study drug. Visit 7: Review of any changes in health or medical treatment, measurement of vital signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated dilation. Visit 8: Review of any changes in health or medical treatment, measurement of vital signs, blood tests, EKG, treadmill exercise testing, brachial artery flow-mediated dilation.
Effects of Ezetimibe Add-On to Statin Therapy on Adipokine Production in Obese and Metabolic Syndrome...
Metabolic SyndromeObesity1 moreThe purpose of this study is to investigate the effects of adding ezetimibe to statin therapy on levels of inflammatory markers and adipokines in patients with atherosclerosis disease and features of the metabolic syndrome,whose LDL-c remains above target (> 2.0 mmol/L) despite statin monotherapy. We hypothesize that the addition of Ezetimibe (10mg per day for 12 weeks) to ongoing statin therapy in patients with atherosclerosis and features of the metabolic syndrome will favourably modify levels of inflammatory biomarkers and adipokines.
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective...
AtherosclerosisThis is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
Cortisone or Drug Eluting Stents (DES) as Compared to Bare Metal Stents (BMS) to EliminAte Restenosis...
Coronary Artery DiseaseIschemic Heart Disease1 moreThe possibility of using the new drug eluting stents (DES) technology has significantly changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced recurrence of angina. The way interventionalists accomplish their work is changing accordingly, with a strong trend to a wider use of DES and a consequent perceived patients' clinical benefit. Evidences supporting the superiority of DES in reducing ischemic recurrence after PCI compared to traditional stents (BMS) are available from randomized studies. A recent meta-analyses underlines that: DES are superior to BMS in reducing clinical recurrence of ischemia, DES and BMS offer identical results in terms of death and infarction, Rapamycin and paclitaxel DES offer similar results. The aim of our study is to perform a multicenter, randomized study to assess the clinical efficacy and safety of the oral prednisone therapy after PCI as a possible systemic alternative to currently available BMS and DES. Furthermore, the study aims at analyzing the clinical outcome of the commercially available DES in the context of an independent research and a cost-benefit comparison with BMS and oral steroids.
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In...
AtherosclerosisThe purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.