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Atherosclerosis clinical trials

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NCT ID: NCT02232321 Completed - Atherosclerosis Clinical Trials

Vascular Effects of Achieving Minimal Disease Activity in Psoriatic Arthritis - a 2 Year Prospective Cohort Study

Start date: March 2014
Phase: N/A
Study type: Interventional

Objectives To investigate the effect of achieving minimal disease activity (MDA) using a protocolized treatment strategy on the progression of subclinical atherosclerosis and arterial stiffness in psoriatic arthritis (PsA) patients. Hypothesis Effective suppression of inflammation in patients who can achieve MDA will have less progression of subclinical atherosclerosis and arterial stiffness then patients who cannot achieve MDA by means of a standardized treatment algorithm aiming at MDA. Design and subjects One hundred consecutive PsA patients will participate in this 2-year prospective, hospital-based, cohort study. Interventions All participants will receive 2-year tight-control treatment. Treatment will be adjusted according to a standardized protocol based on the European League Against Rheumatism (EULAR) recommendation and the Hong Kong guideline on the use of biologics every 4-monthly aiming at MDA. Study instruments Carotid intima-media thickness (IMT) will be measured using high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity (PWV) by a dedicated tonometry system and augmentation index (AIx) by the SphygmoCor device. Main outcome measures and analysis The main outcome measure is the change in IMT over a period of 2 years comparing between patients who achieve MDA at 12 months (MDA group) to those who cannot achieve MDA (non-MDA group). Secondary outcomes include differences in the changes in AIx and PWV over 2 years between the 2 groups. Comparisons of the changes in IMT, AIx and PWV over 2 years between the MDA and non-MDA groups will be performed.

NCT ID: NCT02230254 Completed - Atherosclerosis Clinical Trials

PE PREMIER CHINA CLINICAL TRIAL

Start date: April 9, 2014
Phase: N/A
Study type: Interventional

PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)

NCT ID: NCT02224339 Completed - Atherosclerosis Clinical Trials

New Technologies to Determine Carotid Plaque Vulnerability

CEUS
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle tracking strain indices). Primary Aims: 1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for detection of carotid plaque: - To determine the feasibility and safety of Carotid CEUS and Two-dimensional speckle tracking strain imaging SE . - To determine if carotid CEUS and two-dimensional speckle tracking strain imaging findings are associated with coronary angiographic results in those patients undergoing clinically indicated cardiac catheterization. - To determine the diagnostic accuracy of CEUS in identifying a vulnerable atherosclerotic plaque and neovascularization compared to carotid MRI, in a subset of patients. 2. Evaluate the prognostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for prediction of MACE: - To determine if plaque identification (with or without neovascularization) on Carotid CEUS SE can improve the overall prediction of MACE over stress echo results alone - To determine if Carotid ultrasound two-dimensional speckle tracking strain indices can improve the overall prediction of MACE over stress echo results alone. - To determine if the detection of plaque neovascularization by Carotid CEUS is an independent predictor of MACE (over clinical risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle tracking strain indices).

NCT ID: NCT02223143 Recruiting - Clinical trials for Atherosclerotic Vascular Diseases

A Registration Study for Dyslipidemia

Start date: January 2009
Phase: N/A
Study type: Observational

Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is a leading cause of morbidity and mortality. Dyslipidemia has long been recognized to be the most important risk factor in the development of atherosclerosis in human beings. In Taiwan, the rates for hypercholesterolemia (≧250mg/dl) were 4.3% and 5.5% in 1970; 12.99% in 1980; and 17.1% in 1990. Those for hypertriglyceridemia (≧200 mg/dl) were 6.5% and 11.1% in 1970 and 13.0% in 1990. Low serum HDL-C was an isolated and independent coronary risk factor among a good number of Taiwanese people. Lowering of low-density lipoprotein cholesterol (LDL-C) with statins has in the last decade become part of the standard treatment regimen in patients with dyslipidemia. However, most embarrassing, is the insufficient data for clinical use in Taiwan. It is necessary to have rationalized and balanced guideline for the management of dyslipidemia in Taiwan, based on our local epidemiological, clinical and basic research data. Because all these trials were conducted in Caucasians and no large-scaled end-point research about the lipid lowering therapy (LLT) was published in Asians before, this registry study attempts to define the status of lipid lowering therapy in Taiwan and the effect of LLT on CVD morbidity and mortality in a large population of patients receiving primary or secondary prevention therapy. The medications will only depend on the decision made by the primary care physicians. The patient or physician can decide to be withdrawn from this registry at any time because of any reason. The lipid profile change, myopathy, or liver enzyme change after the LLT will also be recorded.

NCT ID: NCT02214056 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility

DéProPAss
Start date: February 2015
Phase: N/A
Study type: Observational

The main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors.

NCT ID: NCT02212470 Completed - Clinical trials for Cardiovascular Diseases

Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

PAVENST
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

NCT ID: NCT02208765 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prognostic Value of SPECT-imaging Myocardial Perfusion Heterogeneity

EVAPERF
Start date: January 2015
Phase: N/A
Study type: Interventional

Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known CAD. Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown. More over, factual data demonstrate that inhalation of particulate matters and gaz (NO2, CO) from air pollution contributes to the development of cardiovascular diseases in the short and long term. The role of air pollution in endothelial dysfunction has been suggested. Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method applied to routine MP-SPECT. The second purpose is to evaluate the role of air pollution exposure in pathogenesis of cardiovascular disease. The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD. The second hypothesis is that microcirculatory coronary dysfunction is a causal link between air pollution and cardiovascular disease.

NCT ID: NCT02191306 Completed - Clinical trials for Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis

Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy

Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy Intro: It is well known that HIV treated with antiretroviral drugs increases the risk for coronary artery disease. Studies have documented this with various methods including analyzing the effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and hypertension. Still other studies have looked at carotid and brachial artery intimal thickness. Our study, then, aims to evaluate the relationship between HIV medications and coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this test to HIV patients on longstanding antiretroviral therapy to directly examine their coronary arteries to assess heart disease. Hypothesis: We hypothesize that HIV patients on antiretroviral therapy will have increased coronary artery disease compared to the general population. Methods: This project will be conducted in collaboration between Florida Heart Center and Associates in infectious Disease - two communities based infectious disease and cardiology practices. We will identify all the HIV positive patients seen within a 1 month timeframe at the infectious disease office. These patients will then be filtered by our exclusion/inclusion criteria. After obtaining informed consent, we will draw blood from each patient to gather lab values such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate, and severe coronary artery disease. The data, then, will consist of the parameters measured on blood work, and the results of the coronary CTA. Inclusion Criteria: 1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years. Exclusion Criteria: 1. Patients with prior documented coronary artery disease, heart attack, stent placement, or heart surgery. Statistical Analysis: We will conduct a multivariate analysis on the cardiac risk factors taken from patient history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the CTA. We will also conduct basic analysis to support our hypothesis that long term antiretroviral therapy increases coronary artery disease. Funding: The bloodwork and CTA tests ordered in this study will be payed for by insurance companies where available. In cases where insurance companies will not pay, Florida Heart Center will pay for the CTA tests and Associates in infectious Disease will fund the bloodwork. Humans Subjects Protection: This will be a projective chart review study that will require access to protected health information. Thus, we will seek full IRB approval from the FSU IRB committee with informed consent. An informed consent document will be given to each patient explaining all the risks and benefits of the study in addition to the methods. Recruitment will be done by an office staff or medical assistant not on the research team. After patient recruitment, their medical records will be flagged for study and they will undergo the required testing. At completion of testing, their results will be recorded in the final data sheet, and their medical record will no longer be flagged for study. No identifying data will be recorded in the final data sheet, and the data will be stored in an encrypted excel sheet on a secure password protected personal laptop running antivirus and firewall. Third parties (such as family members) will not have access to any research data regardless of authorizations received from the study subjects. All the test results and labwork performed for the study will go into the patient's individual medical record at their respective offices. Thus, if an authorized third party wishes to view any test results, they can do so via the normal methods at the doctor's office.

NCT ID: NCT02183454 Completed - Clinical trials for Coronary Artery Disease

MASCOT - Post Marketing Registry

MASCOT
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

To collect post marketing surveillance data on patients receiving at least one Combo Bio-Engineered Sirolimus Eluting Stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Combo Stent in routine clinical practice.

NCT ID: NCT02169089 Completed - Atherosclerosis Clinical Trials

Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Atherosclerotic disease, or hardening of the arteries, is characterized by the thickening of the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries. High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role in developing clinical symptoms of atherosclerosis disease. The complications of advanced atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack, stroke and/or death and blockage of arteries. This study is being done to assess the effectiveness of Spironolactone therapy to slow down the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of your aortic wall. Spironolactone is an FDA approved drug used to treat heart failure and in the management of hypertension (high blood pressure), but in this study it is used for another unapproved reason. In this study, we would like to evaluate the effects of Spironolactone in people with diabetes and atherosclerotic disease.