Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 20
- 主要终点
- Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG)
研究概览
简要总结
The use of coronary angiography to investigate patients at risk of coronary artery narrowings has become universal. In most cases, this investigation leads to a successful treatment plan with revascularisation recommended where appropriate. However in a substantial number of patients, the images taken of the coronary arteries can lead to diagnostic uncertainty. Increasingly, doctors are using devices called pressure wires to clarify the significance of coronary artery narrowings in order to tailor patient treatment on an individual basis.
The Radi pressure wire is well recognised as a reliable tool in assessing whether a narrowing is significant in functional terms, that is, does it significantly restrict blood flow to the heart muscle.It consists of a fine wire that is fed into individual major coronary arteries to measure pressure within the vessel itself. In conjunction with the images taken of the arteries, it is very useful in deciding how best to treat patients.
This study enrolls volunteers who are being investigated for stable cardiac-sounding chest pain and are undergoing a coronary angiogram. It will investigate whether the extra information gained from pressure wire assessment will change patients' treatment plan.
详细描述
The choice of management in an individual patient is determined largely by the presence and distribution of significant coronary narrowings. Usually, this significance is judged by the visual estimation of a narrowing on an angiogram. However, although this is the standard way of assessing coronary narrowings, it is now widely published that pressure wire measurements are more accurate because they assess the true physiological consequences of the narrowing. Interventional cardiologists now frequently use Fractional Flow Reserve (FFR) measurements to help them decide if arteries require stenting.The hypothesis for this study is that routine measurement of FFR in the main coronary arteries could provide diagnostic information above and beyond that obtained by an angiogram alone. This additional information may well then affect the choice of management in a proportion of these patients. For example, a narrowing considered to be significant angiographically may be shown to be insignificant with FFR, or vice versa.
Background
Coronary artery disease (CAD) is a major cause of morbidity and mortality in the United Kingdom. It accounts for approximately half of all cardiovascular related deaths annually and, according to statistics from the British Heart Foundation, CAD related expenditure was £3,500 million in 2003 alone. Much effort has been placed on improving methods that detect and assess the severity of CAD and facilitate more rapid and appropriate management for CAD patients. Once diagnosed, CAD may be treated in 3 ways: (1)tablets alone, (2)tablets plus angioplasty with stents or (3) tablets plus coronary artery bypass graft surgery (CABG). The method of choice depends primarily on the extent and severity of disease at the time of coronary angiography. Coronary angiography is the current conventional method for the diagnosis of CAD and is used in the assessment of disease severity. For the angiographic procedure,vascular access is secured via the femoral artery or radial artery route and a dye is injected into the coronary artery blood vessels. The progress of the dye through the coronary blood vessels provides a visual assessment of where narrowings are present in the coronary arteries.
Where there is thought to be significant flow obstruction, particularly in symptomatic patients, one of the above three treatments will be offered.
While coronary angiography has revolutionised the management of CAD, the procedure is not without limitation. The purely visual assessment of disease severity with coronary angiography is subjective and patient management can depend on the cardiologist reviewing the films. Many such narrowings can be graded 'moderate' severity and deciding whether these are of haemodynamic significance is notoriously difficult by angiography alone. In recent years, the Radi pressure wire has been shown to provide accurate physiological haemodynamic data about coronary narrowings. Furthermore, the FFR measurement derived predicts clinical outcome, hence giving a 'cut-off' measurement for severity of disease that correlates with the requirement for revascularisation with either stents or surgery. Thus FFR is now frequently used in clinical practice by interventional cardiologists to decide if narrowings require treatment. However, the majority of diagnostic angiography in the UK is performed by non-interventional cardiologists who do not currently have access to the pressure wire technology. In this study, we speculate that if we measure the FFR routinely in all the main coronary arteries of patients undergoing coronary angiography the FFR data obtained may affect the angiogram-derived management of some patients in terms of the choice of tablets/stents/CABG. For example, some narrowings that look significant angiographically may not be haemodynamically important by FFR and vice versa. Clearly this could make a difference between revascularising a patient or not.
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
- 否
入选标准
- •Patients referred for elective coronary angiography under a non-interventional cardiologist for the investigation of chest pain thought to be of cardiac origin.
- •There is no requirement for a test demonstrating objective evidence of myocardial ischaemia because this study aims to recruit consecutive patients in real world current practice
- •Written informed consent
- •No participation in other studies
排除标准
- •Previous coronary artery bypass graft surgery
- •Acute coronary syndrome at presentation
- •Diagnostic angiography or percutaneous coronary intervention within the previous 12 months
- •Contraindication to adenosine
- •Severe valve disease
- •Creatinine >180
- •Life threatening comorbidity
- •Diagnostic angiogram showing "normal" coronary arteries defined as no coronary stenosis of >30% by visual estimate in any epicardial vessel of >2.25mm diameter
结局指标
主要结局
Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG)
时间窗: Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.
This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.
次要结局
- To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data.(Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.)
