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Atherosclerosis clinical trials

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NCT ID: NCT03382249 Withdrawn - Clinical trials for Carotid Atherosclerosis

Sonodynamic Therapy Manipulates Atherosclerosis Regression Trial on Patients With Carotid Atherosclerotic Plaques

SMART-C
Start date: September 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Sonodynamic therapy (SDT) is a new treatment for carotid atherosclerotic plaque. The aim of this study is to assess the safety and efficacy of this technique.

NCT ID: NCT03381872 Completed - Clinical trials for Coronary Artery Disease

Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease

RENOVATE
Start date: May 10, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to compare clinical outcomes between intravascular imaging-guided versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions.

NCT ID: NCT03378024 Enrolling by invitation - Diabetes Clinical Trials

Evaluate the Correlation of NIRS, ABI, Exercise, baPWV and Albuminuria With Peripheral Artery Occlusion Disease (PAD) and Other Atherosclerosis Outcomes

Start date: December 1, 2016
Phase: N/A
Study type: Observational

By utilizing Near infrared spectroscopy (NIRS), the local blood flow, tissue oxygenation (StO2), and recovery time of ischemic leg; can be determined. It is reasonable to standardize an easy, simple and safe Active Pedal Plantarflexion (APP) exercise test working load which can achieve the lowest StO2 and other parameters in ischemic leg through observation of NIRS. After standardized of an effective APP test, a determination of a new cutoff value of resting ABI in diagnosing PAD can probably be searched. Analysing the correlation of baPWV with ABI, atherosclerosis risk factors and parameters with atherosclerosis outcome. Observation the Sequential changes of baPWV, ABI and microalbuminuria after managing the atherosclerosis risks, and analyze their influence on the outcome of PAD, coronary artery disease(CAD) and cerebral vascular disease(CVA) outcomes.

NCT ID: NCT03367663 Completed - Diabetes Clinical Trials

The Effect of Prednisone on Atherogenesis as Studied in the Macrophage Foam Cell Formation Model System.

Start date: January 17, 2018
Phase: Early Phase 1
Study type: Interventional

Glucocorticoids (GCs) are a class of endogenous steroid hormones produced by the adrenal glands and controlled by the hypothalamic-pituitary-adrenal axis (HPA). One of the mechanisms of their action is achieved through ligand-receptor attachment to a class of cytosolic steroid hormone receptors termed Glucocorticoid Receptors (GRs). The formed ligand-receptor complex is a transcription factor involved in gene activation of anti-inflammatory products or repression of pro-inflammatory products [1]. Synthetic forms of GCs are a group of anti-inflammatory and immunosuppressive medications (e.g. Prednisone) that are widely used in clinical practice to treat inflammatory diseases (e.g. Rheumatoid Arthritis, Vasculitis, Asthma). The effectiveness of this class of drugs is limited by numerous adverse effects that include, but not limited to, insulin resistance, glucose intolerance, dyslipidemia, and hypertension, all of which are well known risk factors for cardiovascular diseases (CVD) [2,3]. Furthermore, recent research suggest that inflammation has a key role in development of CVD and can predict prognosis [4]. Inflammatory cells have an important role in the development of atherosclerotic lesion in the arteries. Blood monocyte-derived macrophages are involved in this process, and they infiltrate the lesion where they take up various forms of lipids (cholesterol - rich LDL, and oxidized LDL) as well as triglycerides - rich VLDL), followed by the formation of lipid-laden foam cells, the hallmark of early atherogenesis. Inflammatory cells and molecules as well as proteolytic enzymes secreted from inflammatory cells in the atherosclerotic lesion, have a central role in destabilizing the plaque (vulnerable plaque) leading to its rupture, which, in turn, induces thrombosis, and initiating acute coronary events [4,5]. Based on our understanding of the involvement of inflammation in the early development of atherosclerotic lesion, and our experience with the anti-inflammatory effects of synthetic GCs, a hypothesis emerged suggesting this class of drugs as a way to inhibit early atherosclerotic plaque formation, and to attenuate CVDs [6]. Research results in this field are surprising because while glucocorticoids treatment in humans increase the risk of CVDs [6,7,8,9], animal models shows the opposite, atheroprotection was shown in rabbits [10,11,12] and mice [13,14,15]. This paradox may be explained partially by the fact that clinical studies in this field are mainly conducted in patients with predisposing factors to develop CVD, either because of pre-existing traditional risk factors like Diabetes and Hyperlipidemia, or because of the pre-existing medical condition they are being treated for with GCs (e.g. Rheumatoid Arthritis). Mechanism based research to study the effects of GCs on atherogenesis, without confounding factors, is lacking. Only few studies were performed on GCs in healthy subjects but none of them explored their effects on foam cell formation [16,17]. Our study thus aims to further our understanding of the role of specific glucocorticoid, prednisone, in the process of atherogenesis. In order to achieve that we plan to study the following: 1. The effects of five days of treatment with prednisone on serum lipid concentration and oxidative stress. 2. an Ex-vivo study is planned where the serum of healthy human subjects treated with Prednisone, will be introduced to J774A.1 murine macrophage-like cell line, a well-studied macrophage foam cell formation model.

NCT ID: NCT03355027 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease

INTENSITY-HIGH
Start date: November 30, 2017
Phase: N/A
Study type: Interventional

The INTENSITY-HIGH study aims to answer if there are any limits to LDL reduction in relation to benefiting vascular health, exploring the mechanisms by which secondary prevention in patients with established heart disease may benefit from even lower LDL levels. By using PCSK9 inhibitors such as Alirocumab, very low LDL cholesterol levels not previously encountered in statin trials, can be achieved in patients with established heart disease on top of intensive statin treatment. This research is being carried out because it is unclear what the lowest threshold of LDL cholesterol should be to attain significant reductions in CV risk in stable cardiovascular patients. It is unknown whether there is a true limit of LDL cholesterol below which there is no further improvement in endothelial function in stable cardiovascular patients, and, whether this is associated with a reduction in markers of both systemic and vascular inflammation. Defining this may help identify individuals from the general population who may benefit from more aggressive lipid lowering treatment than standard statin treatment in terms of CV morbidity and mortality. This study will be conducted in patients with stable cardiovascular disease, where they will be randomized to receive either a combination of Alirocumab and statin, or Ezetimibe plus statin. 60 patients will be recruited to this single center, randomized, open label, parallel group, mechanistic physiological study which will be conducted at Cambridge University Hospitals NHS Foundation Trust. In order to be eligible for enrollment to the study, some patients may have to complete a 4 week washout period on a suitable statin therapy. The total study duration for each participant will be approximately 14 weeks, where a series of non-invasive vascular studies and medical imaging assessments which will be conducted to observe vascular/systemic inflammation and to assess endothelial vascular function.This study is funded by JP Moulton Charitable Foundation.

NCT ID: NCT03354156 Completed - Atherosclerosis Clinical Trials

The Effect of Statin Treatment on Trained Innate Immunity

SIMPEL
Start date: January 2015
Phase: N/A
Study type: Observational

The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular trimethylation of lysine 4 at histone 3 (H3K4me3). In this study, the investigators aim to investigate the immunophenotype of circulating monocytes in patients with elevated LDL cholesterol levels and the effect of statins on this phenotype.

NCT ID: NCT03352063 Completed - Metabolic Syndrome Clinical Trials

Prolonged Sitting on Responses to Short-Term Exercise Training

Start date: July 17, 2018
Phase: N/A
Study type: Interventional

Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of prolonged sitting on response to a HFTT after a short term training period.

NCT ID: NCT03335020 Withdrawn - Clinical trials for Atherosclerosis of Artery

Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease

Start date: April 1, 2018
Phase: Phase 1
Study type: Interventional

The researchers are trying to see whether contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-D volume ultrasonography improves arterial wall visualization and identifies arterial elastic properties among individuals with fibromuscular dysplasia (FMD), atherosclerosis, personal history of spontaneous coronary artery dissections (SCAD), or personal history of segmental arterial mediolysis (SAM) that may be different compared to those without the aforementioned conditions.

NCT ID: NCT03333330 Completed - Atherosclerosis Clinical Trials

IMaging Della PLAcca Carotidea

IMPLAC
Start date: April 2012
Phase: Phase 3
Study type: Interventional

Background-White matter hyperintensities (WMH), patchy areas of hyperintense signal on T2-weighted or Fluid Attenuated Inversion Recovery sequences on brain magnetic resonance imaging (MRI), are believed to reflect cerebral burden of ischemic damage and are associated to incident stroke, dementia and eventually mortality in otherwise healthy subjects. Also brain atrophy has been related with presence of carotid atherosclerosis and vascular cognitive impairment. Carotid atherosclerosis may contribute to the genesis of WMH. A recent meta-analysis by our group comprising 5306 subjects was able to demonstrate an association between the presence of carotid atherosclerosis and WMH (odds ratio, OR, 1.42, 95% confidence interval [CI] 1.22-1.66). Objective-To evaluate the relation between carotid artery plaque characteristics, cardiovascular risk factors and brain atrophy/WMH burden analyzed quantitatively as number and volume of lesions and as brain volumes, and progression over 18 months of follow up in subjects asymptomatic for cerebrovascular disease with a carotid artery stenosis <70%.

NCT ID: NCT03329599 Completed - Atherosclerosis Clinical Trials

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Start date: February 14, 2019
Phase: Phase 2
Study type: Interventional

The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.