跳至主要内容
临床试验/NCT02346565
NCT02346565已完成不适用

The Role of Contemporary Stress Echocardiography Techniques in the Initial Assessment of Women With No Previous History of Coronary Artery Disease (CAD) Who Present With Chest Pain of Recent Onset. Stress Echocardiography vs Exercise ECG as First Line Investigation in This Population. Potential for Higher Diagnostic Accuracy Cost Saving.

London North West Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2015年1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
416
试验地点
2
主要终点
Comparison of Positive Predictive Value of each test for Coronary artery disease detection

研究概览

简要总结

The overall question the investigators would like to help answer is whether SE with or without MCE data can be widely used as a first line investigation in women with no previous history of Coronary Artery Disease (CAD) who present with chest pain of recent onset. In order to answer this question the investigators will look at the following:

i) Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of CAD?

ii) What is the additive value of myocardial perfusion data to wall motion data for predicting significant CAD on angiography and future cardiac events in women?

iii) What is the additive value of Carotid ultrasonography in a large population of women referred for stress testing?

详细描述

The investigators plan to perform a prospective study on all women seen in our RACPC with no previous history of CAD and intermediate pre-test probability of CAD as determined by National Institute for Health and Care Excellence (NICE) guidelines, who require a functional test as part of their assessment. All patients that meet the inclusion criteria and do not meet any of the exclusion criteria will be approached for consent to the study.

Patients who can perform greater than 5 metabolic equivalents (METS) on the Duke Activity Status Index (DASI) questionaire will be randomised between undergoing an Exercise ECG (Ex-ECG) or Exercise Stress Echo (ESE). The DASI is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents. Patients who do not meet this criteria, will undergo a pharmacological stress echocardiogram using Dobutamine (DSE), including Myocardial Contrast Echocardiography (MCE). Investigations will continue to be performed as per standard clinical departmental protocols as described below. In addition, all patients will undergo carotid ultrasonography. The techniques used are described for completeness as they are all well-established in clinical practice.

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

入选标准

  • Age 30 years and above
  • No previous history of Coronary Artery Disease
  • Chest pain of presumed cardiac origin, which has occurred in the last month prior to the clinic appointment.

排除标准

  • Electrocardiogram diagnostic of cardiac ischaemia and/or infarction (ST-segment deviations>0.5mm, or T-wave inversion).
  • Previous history of Coronary Artery Disease
  • Chest pain in the last 24 hours
  • Inability to provide informed consent
  • Pregnancy

结局指标

主要结局

Comparison of Positive Predictive Value of each test for Coronary artery disease detection

时间窗: 2 years

To compare positive predictive value of each test for the detection of obstructive CAD defined as ≥ 70% luminal diameter narrowing in one or more epicardial coronary arteries or their major branches during invasive coronary arteriography

To compare the use of Downstream resource utilisation following allocated functional tests

时间窗: 2 years

Comparison between the number of follow-up investigations, clinic visits and hospitalisation for patients in the 2 test groups.

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 (2)

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