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临床试验/NCT01149590
NCT01149590已完成不适用

Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic

University of Edinburgh24 个研究点 分布在 1 个国家目标入组 4,138 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,138
试验地点
24
主要终点
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease

研究概览

简要总结

The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.

详细描述

Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 and ≤75 years of age
  • Attendance at the Rapid Access Chest Pain Clinic

排除标准

  • Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
  • Severe renal failure (serum creatinine >200 µmol/L or estimated glomerular filtration rate <30 mL/min)
  • Previous recruitment to the trial
  • Major allergy to iodinated contrast agent
  • Unable to give informed consent
  • Known pregnancy
  • Acute coronary syndrome within 3 months

结局指标

主要结局

Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease

时间窗: 6 weeks

次要结局

  • Symptoms(Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months)
  • Investigations(Baseline, 6 weeks, 6 months)
  • Diagnosis(Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months)
  • Treatment(Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months)
  • Long-term outcome(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (24)

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