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Plaque, Atherosclerotic clinical trials

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NCT ID: NCT05156736 Recruiting - Stroke Clinical Trials

Pakistan Study of Premature Coronary Atherosclerosis in Young Adults

PAKSEHAT
Start date: March 15, 2023
Phase:
Study type: Observational

Coronary heart disease (CHD) is a major cause of morbidity, disability, mortality, and health expenditures worldwide. A wealth of studies has demonstrated that people of South Asian ancestry have a higher risk of CHD and particularly premature CHD than most other racial/ethnic groups, and recent research suggests that this risk is higher in Pakistanis than in Indians-the two largest SA groups. Pakistan is the 5th most populous country in the world, and despite these concerning trends, so far there has been a scarcity of large studies evaluating the prevalence of cardiovascular risk factors and subclinical coronary atherosclerosis in young-to-middle-aged Pakistanis. Also, there is currently no cardiovascular risk score specifically tailored to younger Pakistani men and women. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims at addressing these important gaps. PAK-SEHAT is an ongoing prospective cohort study that will enroll 2,000 asymptomatic Pakistani men aged 35 to 60 years and women aged 35 to 65 years from the general population, free of clinically overt cardiovascular disease. Participants will undergo a comprehensive baseline exam including coronary computed tomography angiography, and will be followed for incident events and repeat testing for 5 years. PAK-SEHAT will allow determining the prevalence, severity, determinants, and prognostic significance of early atherosclerosis in apparently healthy young-to-middle-aged Pakistanis. This knowledge can help inform primordial and primary prevention strategies, enhanced cardiovascular risk stratification, and potential plaque-screening approaches in Pakistan, all of which can ultimately help reduce the burden of CHD in the country. In this report investigators describe the rationale, objectives, methods, and discuss the potential implications of the PAK-SEHAT study.

NCT ID: NCT05123287 Recruiting - Clinical trials for Carotid Artery Plaque

A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

Start date: October 8, 2021
Phase:
Study type: Observational [Patient Registry]

A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

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: 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.

NCT ID: NCT04539223 Recruiting - Clinical trials for Carotid Artery Stenosis

A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy

SLICE-CEA
Start date: August 28, 2020
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.

NCT ID: NCT04470687 Recruiting - Carotid Stenosis Clinical Trials

Ultrafast Ultrasound Imaging Assesment of Carotid Plaque Neovascularization

ULTRA-VASC
Start date: March 17, 2021
Phase: N/A
Study type: Interventional

Stroke is the second leading cause of death in the Western world and the leading cause of major lifelong disability. About 15% of strokes are secondary to thrombosis or embolization of an unstable atheromatous carotid plaque. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. Patients with stenosis over 70% are therefore offered an endarterectomy, an operation to remove carotid plaque, to prevent future strokes[1]. In asymptomatic patients, the degree of stenosis is a limited predictor, and better risk stratification is required to assess the degree of plaque vulnerability and stroke risk of the patient. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable and dependent benefit/risk balance for each patient. A number of imaging parameters have been studied: ulceration, heterogeneity, vascularization of the plaque for example, but their place is not well defined [2]. The usual evaluation of carotid stenosis is by conventional Doppler ultrasound with calculation of the degree of stenosis according to the NASCET criteria. For symptomatic stenoses the intervention is recommended when above 70% and is discussed from 50% to 70% of NASCET stenosis degree. For asymptomatic stenoses, the procedure is discussed when above 60% taking into account the patient's life expectancy, the risk of the surgery and the unstable nature of the plaque [2]. Destabilization of the carotid plaque is partially induced by inflammation associated with neo-vascularization. The detection of these new vessels by conventional contrast ultrasound has already shown a distinction between stable and unstable plaques, by the presence or absence of microbubbles in the plaque. However, this assessment is not very precise and only the most vascularized plaques can be detected. Ultrafast ultrasound Imaging is a new ultrasonic Imaging modality that allows detecting low speed flows, a tiny vascular structure within the vessel wall. RESEARCH HYPOTHESIS Plaques neo-vascularization would be more precisely detected and characterized by ultrafast imaging coupled with microbubble injection than conventional ultrasound imaging. A better assessment of plaque instability could improve the selection of patients for carotid endarterectomy and increase the benefit/risk ratio of this preventive surgery.

NCT ID: NCT04237064 Recruiting - Clinical trials for Carotid Artery Plaque

Photoacoustic Imaging of Atherosclerotic Plaques

Start date: February 2, 2019
Phase:
Study type: Observational

Stroke is a major cause of death and disability worldwide. Stenotic carotid arteries can lead to stroke if the cause of the stenosis is a vulnerable atherosclerotic plaque. Recent studies reveal that if a patient has a plaque in the carotid artery it is highly probable that he/she will develop plaques in other superficial arteries like the femoral artery. Currently, duplex ultrasound is used to determine the grade of stenosis and is the main criterion for intervention (endarterectomy) planning. However, the stability, or instability of the plaque cannot be determined non-invasively. Photoacoustics is a novel, non-invasive imaging modality that uses pulsed laser light to generate laser induced ultrasound in the absorbing region of the tissue. Photoacoustic imaging provides optical contrast of biological tissue chromophores with an acoustic resolution and imaging depth, which is promising for visualization of plaque composition. The advantage of photoacoustics is the use of multiple wavelengths, since different tissues respond differently to different wavelengths. Hence, non-invasive, in vivo, morphology assessment is a future application of this new modality that would improve diagnosis and clinical decision making. The drawback is the limited penetration depth of the laser light and the signals generated by surrounding tissue. A new, integrated photoacoustic device has been developed that meets all safety requirements and has an improved penetration depth, suitable for imaging of carotid arteries with the aim to distinguish between plaques with different morphology.

NCT ID: NCT04185493 Recruiting - Clinical trials for Coronary Artery Disease

Coronary Artery Geometry and the Severity of Coronary Atherosclerosis

GEOMETRY-CTA
Start date: June 4, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate the potential association of coronary artery geometry, based on coronary CT angiography (CCTA), with the complexity and the severity of coronary atherosclerosis.