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临床试验/NCT01464203
NCT01464203Unknown不适用

Randomized Controlled Trial to Evaluate the Cost and Clinical Effectiveness of CT Coronary Angiography in Patients With Stable Angina Pectoris (RADICAL Trial)

AJAY YERRAMASU6 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2009年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
6
主要终点
Cost of diagnosis

研究概览

简要总结

Heart disease remains the most common cause of death in the UK. Chest pain is often the first presenting symptom in patients with heart disease, and may be a warning signal prior to a heart attack or death. The diagnosis based on symptoms alone however is unreliable and further testing is almost always necessary.

Rapid access chest pain clinics (RACPCs) are able to expedite the assessment of such patients. The principal investigation used is an exercise stress electrocardiogram (s-ECG). Although simple, cheap, and convenient, the s-ECG is often inaccurate; missing the diagnosis or falsely suggesting the diagnosis. This can happen in as many as 25% of patients, resulting in a delay in treatment or unnecessary further investigation.

CT Angiography (CTA) is a novel non-invasive technique where the coronary arteries can be visualised by Computerised Tomography. In previous studies it shows a high degree of correlation with invasive angiography, with a high accuracy for the diagnosis of obstructive coronary artery disease. However, the technique is relatively new, and its full role is yet to be defined in the clinical setting of a chest pain clinic. The investigators do not at present have any information as to whether it is able to speed up the diagnosis, reduce the need for other tests, and therefore also costs.

In this trial, the investigators aim to examine the accuracy and cost effectiveness of CTA in patients with suspected cardiac chest pain presenting to a chest pain clinic, when compared to the more established techniques like s-ECG, myocardial perfusion scanning and coronary angiography. The study will enable us to establish the optimal and most cost effective strategy for investigation of patients presenting to chest pain clinics.

详细描述

Study Objectives:

  • To assess the diagnostic accuracy and cost effectiveness of non-invasive coronary angiogram by Cardiac CT in the diagnosis of coronary artery disease in patients with angina, in the setting of Rapid Access Chest Pain clinics
  • To formulate an optimal diagnostic algorithm in terms of accuracy and cost effectiveness for diagnosis of CAD in patients with chest pain.

Study Setting:

  • Rapid Access Chest Pain clinics in 3 NHS hospitals (Barnet, Chase Farm and the Royal Free hospitals)

Target Population:

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

入选标准

  • chest pain or shortness of breath suspected to be due to coronary artery disease

排除标准

  • Age < 40 years
  • Pregnancy
  • Serum Creatinine > 150 mmol/L or eGFR < 40
  • Established or suspected acute coronary syndrome
  • Previous history of PTCA
  • Atrial Fibrillation
  • History of allergy to iodinated contrast media

结局指标

主要结局

Cost of diagnosis

时间窗: one year

次要结局

  • Diagnostic Accuracy of CT coronary angiography(one year)
  • Quality of life(one year)
  • Number of normal invasive coronary angiograms(one year)
  • Number of invasive coronary angiograms not followed by coronary revascularization(one year)
  • Prognostic value of CT coronary angiography(1 year)

研究者

发起方
AJAY YERRAMASU
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

AJAY YERRAMASU

Clinical Research Fellow

Wellington Hospital

研究点 (6)

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