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临床试验/NCT05071417
NCT05071417尚未招募3 期

Effect Of Semaglutide In Coronary Atherosclerotic Plaqus Assessed by Coronay CT

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León0 个研究点目标入组 120 人开始时间: 2021年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
120
主要终点
Plaque burden modification assessed by coronary CT and plaque quantification

研究概览

简要总结

The main objective of this trial is to evaluate the effect of Semaglutide on the burden of coronary atherosclerosis, based on the change in Percent Atheroma Volume (PAV) by quantifying atheroma plaque throughout the coronary tree based on the analysis of CCTA in asymptomatic subjects with T2D in optimized and stable treatment with Semaglutide.

详细描述

Patients with type 2 diabetes mellitus (DM2) are considered to be at high vascular risk (VR). However, the VR risk may vary, depending on the presence of other cardiovascular risk factors (CVRFs), particularly dyslipidemia, smoking habit, hypertension, and obesity. High blood glucose levels are part of the etiopathogenic basis of atherosclerosis, whose vascular complications are the leading cause of death and disability in developed countries. Atherosclerosis is considered a chronic immunoinflammatory process with a polygenic and multifactorial origin that begins early due to vascular endothelial dysfunction. Atherosclerosis is a dynamic process that develops intermittently over time; periods of inactivity and rapid evolution are interspersed and modulated by environmental and genetic factors. As a result of a series of etiopathogenic and environmental factors, lesions (plaques) develop with greater or lesser lipid content, collagen, elastic fibers, and calcium. The location and degree of development of atherosclerotic plaques give rise to different forms of atherosclerotic disease, which is characterized by symptoms and signs that correspond to the obstruction of the vascular lumen with decreased flow and the consequent occurrence of (possibly chronic) ischemia. Atherosclerotic disease can also be characterized by the rupture of the plaque and the appearance of thrombotic phenomena (because the lipid nucleus of the plaque is highly thrombogenic and triggers the activation of the coagulation and platelet adhesion and aggregation cascades), with manifestations of acute ischemia.

The relationship between the composition of the atheroma plaque and the occurrence of cardiovascular events, revealed the need for imaging techniques that could identify not only the degree of stenosis of atherosclerotic lesions, but also their volume, composition and levels of inflammation, and thus being able to identify the possible high-risk plaques (vulnerable plaques). Within imaging techniques, there are invasive ones such as coronary angiography or coronary angiography, ultrasound or intravascular ultrasound (IVUS) and optical coherence tomography (OCT); and non-invasive, such as magnetic resonance imaging (MRI), positron emission tomography (PET), and computed tomography.

Invasive coronary angiography has traditionally been the reference imaging test to determine the degree of stenosis and continues to be the procedure of choice for the evaluation of coronary anatomy and the identification of atherosclerotic lesions. Angiography provides information on the number and size of vascular stenosis but does not allow to know the plaque composition. Provides Simply an image of the internal arterial lumen but lacks the ability to adequately represent the vessel wall with its developing atherosclerotic plaque.

Intravascular ultrasound (IVUS) is considered the reference method for the evaluation of atherosclerotic plaque burden and plaque characteristics. However, IVUS is an invasive method that has risks, cannot be used to study the entire coronary tree, only in one segment of the arterial tree and is not indicated for asymptomatic individuals.

The IVUS technique plus virtual histology allows the identification of atheroma plaques in the vascular tree, and can quantify the size, volume, composition and distribution of the plaque. However, a limitation of this technique is the ability of the ultrasound signal to penetrate the calcified tissue, resulting in an acoustic shadow after the calcified tissue.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ≥35 and ≤ 65 years
  • Absence of previous history of clinical cardiovascular events
  • Subjects already taking therapy for diabetes on stable doses for 3 months or more.
  • Subjects must have HbA1c at the initial screening visit between 8 and 10%
  • Coronary CT performed less than 3 months before starting study medication

排除标准

  • Clinically significant heart disease
  • New York Heart Association (NYHA) class >II
  • Known stroke or transient ischemic accident
  • Uncontrolled hypertension at randomization, defined as a resting systolic blood pressure of 180 mm Hg at rest
  • Personal or family history of hereditary muscular disorders
  • Fasting triglyceride level > 250 mg/dL at screening
  • Type 1 diabetes
  • Known thyroid disease or subject taking thyroid replacement therapy
  • Estimated glomerular filtration rate < 60 ml/min/1.73m2
  • History of malignancy
  • Known major active infection, or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
  • Baseline coronary CT does not meet Core Lab technical standards
  • Cardiac rhythm different to normal sinus rhythm.
  • Female subjects cannot be pregnant or breastfeeding, planning to become pregnant or planning to breastfeed during the entire study
  • Premenopausal females of childbearing potential must be willing to use an acceptable method(s) of birth control during treatment and for an additional 15 weeks after the end of treatment

研究组 & 干预措施

Semaglutide

Experimental

Patients on semaglutide

干预措施: Semaglutide (Drug)

结局指标

主要结局

Plaque burden modification assessed by coronary CT and plaque quantification

时间窗: 18 months

The main objective of this trial is to evaluate the effect of Semaglutide on the burden of coronary atherosclerosis, based on the change in Percent Atheroma Volume (PAV) by quantifying atheroma plaque throughout the coronary tree based on the analysis of CCTA in asymptomatic subjects with T2D in optimized and stable treatment with Semaglutide

次要结局

  • Atheroma volume modification assessed by coronary CT and plaque quantification(18 months)
  • Percentage of patients with significant plaque regresion assessed by coronary CT(10 months)
  • Changes in composition of artery wall assessed by coronary CT and plaque quantification(18 months)
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(18 months)
  • Incidence of cardiovascular events(18 months)

研究者

发起方
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
申办方类型
Other
责任方
Principal Investigator
主要研究者

PM1-SEPLA IBSAL

Professor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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