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临床试验/NCT06311071
NCT06311071已完成不适用

The Utility of Coronary Artery Calcium Score for the Prediction of Coronary Artery Disease in Patients With Cardiac Symptoms; a Diagnostic Study

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
498
试验地点
1
主要终点
coronary calcium score

研究概览

简要总结

In this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( CAD) were enrolled. Patients underwent CT scans to measure coronary artery calcium score (CACS), and total calcium scores were recorded. Then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing CAD (defined as at least one stenotic coronary artery with ≥ 50%). Framingham risk score (FRS) was also estimated for all the patients

详细描述

In this prospective study 498 patient who referred to cardiology clinic with any cardiac symptoms and positive noninvasive tests without preestablished coronary artery disease ( CAD), were enrolled. All the patients underwent coronary artery calcium score (CACS) testing, and total calcium scores were recorded. A calcium score of zero was considered as having very low risk for CAD. A score of 1 to 99 was defined as having low risk, 101 to 299 as having intermediate risk, and 400 or more as having high risk for CAD. Then, invasive (conventional) coronary angiography by radial access, as the gold standard for the diagnosis of CAD, was performed for all of the involved participants.

Coronary artery stenosis equal to or more than 50% was considered as a significant narrowing [25]. Patients with at least one diseased coronary artery with a significant narrowing were considered to have CAD. Minor branches were considered only if their main supplying branch was not diseased. A group of expert interventional cardiologists performed and reported coronary angiographies. The study was single-blind; cardiologists were unaware of the results of CAC scores when performing conventional coronary angiographies

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age over 40 years, having cardiovascular symptoms (including chest pain, dyspnea on exertion, etc.), and positive primary non-invasive tests, such as myocardial perfusion imaging (MPI) or exercise tolerance test (ETT)

排除标准

  • Previously diagnosed coronary artery disease
  • Cerebrovascular accident (CVA)
  • Peripheral artery disease
  • Pregnancy
  • Medical instability
  • Hypersensitivity to contrast materials
  • Having atrial fibrillation

结局指标

主要结局

coronary calcium score

时间窗: 1 year

calcium score obtained from coronary CT angiography, 0 no risk, 0-100 low risk, more than 100 high risk

coronary artery disease

时间窗: 1 year

stenosis more than 50% in selective coronary angiography

次要结局

  • cardiovascular risk score(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javad Kojuri

professor

Shiraz University of Medical Sciences

研究点 (1)

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