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Plaque, Atherosclerotic clinical trials

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NCT ID: NCT05096637 Not yet recruiting - Clinical trials for Atherosclerotic Plaque

Digital Secondary Prevention in Cardiovascular Disease

Start date: November 2021
Phase: N/A
Study type: Interventional

Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world. Cardiac rehabilitation (CR) and secondary prevention are coordinated multidimensional evidence-based strategies that aim to assist patients with acute and chronic ischemic heart disease return to an active and satisfying life and to prevent the recurrence of further cardiac events. Since CR is time limited after an acute event, secondary prevention proposes a continuum where care is provided for the rest of a person's life according to the existence of cardiovascular risk factors. Secondary prophylaxis is fundamental for the recovery of the patient, but in most cases, it is only insufficiently implemented. To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved in their own care. Mobile health (mHealth) is a rapidly growing health delivery methodology with the potential to impact on health care research, health care delivery and health outcomes. Therefore, the aim of the study is to determine the impact of plaque visualization using a digital intervention on treatment adherence to improve the cardiovascular risk profile. Participants will be randomized into two groups: intervention group and control group. Participants of the control group receive the best medical care according to current guideline recommendations without access to the app. Participants of the intervention group receive the best medical care according to current guideline recommendations with full access to the Smartphone application at time of study begin until the completion of the follow-up period of 12 months. The access to the app includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight.

NCT ID: NCT05040958 Recruiting - Metabolic Syndrome Clinical Trials

Carotid Atherosclerotic Plaque Load and Neck Circumference

Start date: September 8, 2021
Phase:
Study type: Observational

The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.

NCT ID: NCT04922541 Recruiting - Clinical trials for Plaque, Atherosclerotic

Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Start date: November 1, 2019
Phase:
Study type: Observational

Multi-center Observational Study on the Progression of Atherosclerotic Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

NCT ID: NCT04853511 Recruiting - Inflammation Clinical Trials

Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability

Start date: February 14, 2022
Phase:
Study type: Observational [Patient Registry]

Emotional stress is associated with future cardiovascular events. However, the biological interconnection between brain emotional neural activity and acute plaque instability is not fully understood. Optical coherence tomography-Fluorescence Lifetime (OCT-FLIM) dual modal intravascular imaging is a novel technique that enables comprehensive assessment of structural and biochemical characteristics of coronary atheroma and estimates the level of plaque instability. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including emotional stress, arterial inflammation, and hematopoiesis. The present study aims to prospectively investigate mechanistic linkage between coronary plaque instability, stress-associated neurobiological activity, and macrophage hematopoiesis using OCT-FLIM and 18F-FDG PET/CT imaging assessment.

NCT ID: NCT04835467 Completed - Atherosclerosis Clinical Trials

First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.

NCT ID: NCT04754880 Completed - Clinical trials for Coronary Artery Disease

Coronary Chronic Total Occlusion and Oxidative Balance

Start date: January 1, 2018
Phase:
Study type: Observational

The presence of chronic blockage of coronary arteries, which we may accept as the terminal point of atherosclerotic coronary artery disease, is closely associated with a poor prognosis. The Discovery of markers that may distinguish patients with a high risk of chronic total occlusion development among patients monitored with the diagnosis of stable coronary artery disease may be important for being able to reduce the increased mortality and morbidity rates. Oxidative stress status may be one of the markers that play a role in and/or show the development of chronic total occlusion. It was reported that it has a role in the progression, erosion, and instability of atherosclerotic plaques in coronary arteries. To the best of our knowledge, the relationship between chronic total occlusion development and oxidative stress status in stable coronary artery disease has not been studied. This study investigated the relationships in the oxidative stress status evaluated over TAS, TOS, OSI, Thiol/Disulfide Homeostasis, and antioxidative vitamin levels and possible differences in patients with noncritical coronary artery disease and those with chronic total occlusion.

NCT ID: NCT04701385 Completed - Clinical trials for Atheroma; Myocardial

Plaque Erosion Prospective Study ii

PEPSii
Start date: October 15, 2020
Phase:
Study type: Observational

Plaque erosion is associated with myocardial infarction (MI) in about 30% of cases and may require a different management approach to plaque rupture. The investigators hypothesise that plaque erosion leads to higher levels of apoptotic circulating endothelial cells (CECs) compared to plaque rupture. Aims: To compare associations between plaque erosion and plaque rupture with numbers and types of apoptotic CECs in patients with non-ST elevation MI (NSTEMI) and stable coronary artery disease controls (CAD). Additional aims are to explore signals of cellular stress (mitochondrial dsDNA), sub-populations of activated neutrophils, circulating endothelial progenitor cells and erosion-specific plasma biomarkers. Methods: Prospective observational study of 80 patients with NSTEMI and 40 patients with stable CAD. Plaque erosion or rupture will be identified by intracoronary Optical Coherence Tomography (OCT). CECs and neutrophils will be quantified and characterised using flow cytometry looking at markers of cell death and neutrophil activation. Plasma will be analysed by proteomic methods (Olink) and for mitochondrial dsDNA. Potential importance of findings: This study will provide evidence for the hypothesised mechanism of plaque erosion and clarify if biomarker analysis in NSTEMI patients provides a basis for non-invasive diagnosis of plaque erosion versus rupture.

NCT ID: NCT04691726 Completed - Surgery Clinical Trials

Impact of Intra- and Postoperative Continuous Infusion of Lidocaine on Analgesia in Vascular Anaesthesia

Start date: January 29, 2019
Phase: Phase 4
Study type: Interventional

The aim of the study is to test the effectiveness and safety of the use of lidocaine infusion in multimodal analgesic management. A group of patients undergoing vascular surgery performed with the classic technique on the aorta - with the opening of the abdominal cavity will be enrolled. The population of patients qualified for this type of vascular surgery is usually burdened with multiple diseases, mainly risk factors or cardiovascular diseases, which, combined with hemodynamic fluctuations, large fluid shifts (including bleeding) and stress for the body, affects the risk of serious cardiological complications, which in this group exceeds 5% and is the highest, according to the ESC / ESA (European Society of Cardiology / European Society of Anesthesiology) classification from 2014. Proper postoperative pain control is therefore becoming one of the key pillars of postoperative care in this group of patients. Due to the numerous disease burden of patients and the operational specifics, the use of multimodal therapy in the management of pain is of particular importance, as the use of high doses of opioids improves hemodynamic stability, but at the same time affects the occurrence of side effects - mainly excessive sedation, respiratory disorders, hypoventilation and, consequently, for hypoxia of the heart muscle. The risk of myocardial injury in non-cardiac surgery (MINS) is significant in the light of the available literature. Lidocaine used in intravenous infusion is one of the recommended components of multidirectional analgesia. Its adjuvant properties make it possible to reduce the amount of opioid drugs used, and thus - to reduce the frequency of their side effects. The high effectiveness of such a procedure has been proven in numerous experimental and epidemiological studies. Due to the low frequency of side effects associated with its use, the therapy has a strong recommendation for use in relieving perioperative pain. The analysis of the literature on the subject shows that there is little data assessing effectiveness of lidocaine infusion in relation to the group of patients after surgery on the abdominal aorta.

NCT ID: NCT04652973 Active, not recruiting - Prostatic Neoplasms Clinical Trials

Evaluation of Atherosclerotic Plaques in Abdominal CT Studies

Start date: November 19, 2020
Phase:
Study type: Observational

Background: Fat and calcium can build up as plaque in artery walls. The Agatston score measures plaque using computed tomography (CT) that does not use an injected contrast agent. Plaque in the arteries of the pelvis and abdomen is linked to cardiovascular disease (CVD) risk factors. It also may affect cancer. But abdominal CTs use a contrast agent (CECT). Therefore, the Agatston score cannot be used. Researchers want to find a way to measure plaque in CECTs. This will help them use abdominal CTs to measure plaque without extra radiation. Objective: To measure atherosclerotic plaques on CECT in a group of males. Eligibility: Men ages 30-90 with prostate cancer (proven with biopsies) who have abdomen CT studies in the PACS (picture archiving system) in the Clinical Center. Also, men or women of all ages who have multiphase abdomen and pelvic CT studies that are in the PACS. Design: This study will use data gathered since 1/1/2013. Data will also be taken from protocol 03-CC-0128 and clinical trials 15-C-0124, 16-C-0048, 14-C-0112, and 04-C-0274. Participants from these studies have allowed their samples to be used in the future. Participants will be found via keyword searches on NIH databases. Their CT and MRI scans will be used. Data such as age, race, disease, and treatment will be used. Results of other tests may be used. The plaque in participants abdomen and iliac arteries will be measured. It will be compared with biomarkers related to CVD and prostate cancer, such as weight, age, and race. This study will take place at one site. Data will be stored on secure computers. Printouts will be kept in locked rooms.

NCT ID: NCT04559191 Recruiting - Clinical trials for Coronary Atherosclerosis

Atheroma Progression and Vulnerability Under Continuous Glucose Monitoring

OPTIMAL
Start date: March 1, 2019
Phase: Phase 4
Study type: Interventional

The OPTIMAL is a single-center, randomized trial to evaluate the efficacy of CGM-based glycemic control on atheroma progression in T2DM patients with CAD by using serial intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) imaging. A total of 90 eligible subjects will be randomized 1:1 into 2 groups to receive either CGM-based glycemic control or HbA1c-baded glycemic management. Coronary angiography and NIRS/IVUS imaging is repeated at the end of the assigned treatment period. Results: The primary endpoint is the normalized absolute change in total atheroma volume from baseline to 12 months. The secondary endpoints include (1) the absolute change in percent atheroma volume, (2) the percent change in lipid core burden index, (3) the change in coefficient variance measured by CGM, (4) the change in atherogenic markers (high-density lipoprotein functionality, proprotein convertase subxilisin/kexin type 9 and fatty-acid binding proteins), and (5) the frequency of hypoglycemia. Safety will also be evaluated.