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临床试验/NCT07696533
NCT07696533招募中不适用

Carotid Ultrasound Vs Computed Tomography (CT) Coronary Calcium Scoring to Reclassify Symptomatic Patients With Suspected Chronic Coronary Syndrome Using Risk Factor Clinical Likelihood for Obstructive Coronary Artery Disease

London North West Healthcare NHS Trust1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2026年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
1
主要终点
1. Reclassification of patients based on detection of carotid plaques defined as: a. Patients with no carotid plaques will reclassify as very low likelihood (<5%) b. Patients with 1-2 plaques as low likelihood for obstructive CAD (5-15%) c. Patients with

研究概览

简要总结

  • Chest pain is one of the most common symptoms of heart disease. This could be due to narrowing in heart's blood vessels, which needs to be investigated.
  • Currently, people with a low risk of narrowing of heart vessels usually have a CT scan of the heart first. This scan is good at identifying those who do not have significant narrowing. However, the scan has some drawbacks, such as exposure to a small amount of radiation.
  • We are exploring if ultrasound of the neck vessels might give us similar kind of information as the CT scan.
  • You will be asked to attend the hospital for one visit to have an ultrasound scan of your neck.
  • The findings of your neck vessels will be compared with the CT scan of your heart vessels to see if there is a similarity.

详细描述

In the era of rising coronary artery disease burden, various investigations ranging from CTCA, SE, CMR, PET, SPECT and CA are being extensively relied upon to detect CAD and prevent CVD events. According to current guidelines, patients falling in the subgroup of low likelihood of obstructive CAD are investigated with CTCA and CAC score as the first line of investigation to rule out obstructive coronary artery disease [6,8]. Based on the CACS-CL alone, the low-risk RF-CL patients can be reclassified to identify more patients with very low risk of obstructive CAD, thereby allowing for deferral of further testing [6]. This method has demonstrated a high degree of reliability in the process of downgrading patients from the low-likelihood subgroup to the very-low-likelihood of obstructive CAD subgroup [29]. The reclassification of patients to the 'very low likelihood of obstructive CAD' subgroup is important, as it ensures that patients can be safely reassured, with no further requirement for investigations for obstructive CAD and at the same time reduces pressure on already compromised resources. In order to determine the CAC score, patients are exposed to ionising radiation. It is not only expensive but also requires advanced equipment, while carotid ultrasound offers a safer, quicker and more affordable option without radiation. With growing evidence connecting carotid plaque with CAD in both asymptomatic and symptomatic individuals, its role in risk reclassification of symptomatic patients warrants further investigation. The objective of this study is to determine the accuracy of carotid ultrasound in reclassifying a specific patient subgroup compared to CAC score. Should carotid ultrasound be able to demonstrate the desired accuracy as of CAC score in this sub-group, it would be feasible to investigate such patients without exposure to ionising radiation or iodinated contrast, while concomitantly reducing costs.

研究设计

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

入排标准

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

入选标准

  • Age > 18 years old
  • Symptomatic patients with suspected CCS, judged by the clinician to require CTCA with CAC scoring, for the diagnosis of CAD
  • Have a RF-CL 5-15%, as calculated using ESC guidelines
  • Able to give informed consent to participate in the study and its follow up

排除标准

  • Age <18 years old
  • Diagnosed ACS requiring hospitalization or urgent or emergent testing
  • Known CAD with prior MI, PCI, CABG or any angiographic evidence of CAD (≥50% lesion in a major epicardial vessel)
  • History of previous stroke or known peripheral vascular disease
  • Known significant cardiac congenital abnormalities
  • Life expectancy < 1 years
  • Unable to provide written informed consent

研究组 & 干预措施

Carotid Ultrasound

Experimental

干预措施: Carotid Ultrasound (Diagnostic Test)

结局指标

主要结局

1. Reclassification of patients based on detection of carotid plaques defined as: a. Patients with no carotid plaques will reclassify as very low likelihood (<5%) b. Patients with 1-2 plaques as low likelihood for obstructive CAD (5-15%) c. Patients with

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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