A Randomised Controlled Trial of Very Early Angiography +/- Intervention Versus Standard of Care on Outcomes in Patients With Non ST-elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events
研究概览
简要总结
Prospective, open, multicentre, randomised controlled trial in patients with higher risk non-ST elevation myocardial infarction acute coronary syndrome
详细描述
Background: Clinical event rates in Non ST elevation myocardial infarction acute coronary syndrome (N-STEMI ACS) patients remain high, with one year MACE rates as high as 20%. While there may be early mortality differences between N-STEMI and STEMI, outcomes beyond one year become very similar. N-STEMI ACS patients therefore rightly remain the focus of a number of research directives. The objective of the RAPID-NSTEMI trial is to determine if clinical outcomes can be improved by very early intervention in a pre-determined higher risk N-STEMI ACS population. Published data has shown that inpatient Percutaneous Coronary Intervention (PCI) in N-STEMI ACS patients reduces subsequent clinical events. This had led to guidelines supporting its use in clinical practice. However, there is much less certainty regarding the timing of the PCI and, in particular, whether this should be a strategy used early to optimize outcomes. Thus, while evidence based guidelines (NICE and European) provide general time parameters for PCI, immediate angiography with a view to intervention in higher risk patients has never been robustly tested in any adequately powered, prospective randomised trial with clinical end points. The RAPID-NSTEMI trial sets out to test the benefits, or otherwise, of a strategy of immediate angiography with follow-on revascularisation in higher risk N-STEMI ACS patients.
Hypothesis: Very early angiography +/- PCI improves clinical outcomes in higher risk NSTEMI patients when compared to standard invasive management.
Methods: In order to identify higher risk patients as soon as possible after presentation, a high sensitivity troponin (Hs-Troponin-T or Hs-Troponin-I) will be taken, allowing calculation of a GRACE 2.0 score (GS 2.0) early after admission. The GS 2.0 will be determined in sufficient time to be able to test an early intervention strategy arm. Patients with GS 2.0 of ≥118 alone, or ≥90 with additional high risk features will be randomised in a 1:1 fashion to one of two groups:
Group A: immediate angiography with follow-on revascularisation if required Group B: standard care - pharmacological treatment until angiography with follow on revascularisation if required (preferably within 72 hours as per current guidelines).
The primary outcome for the main study will be a 12-month of all-cause mortality, new myocardial infraction and hospital admission with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 years of age and over
- •Patients presenting to hospitals with a clinical diagnosis of non-ST elevation myocardial infarction comprising:
- •Ischaemic symptoms (as defined in Appendix III of protocol)
- •Elevated high sensitivity Troponin T or I (above the normal range for individual hospitals)
- •GRACE-2.0 score (www.gracescore.org) of either:
- •≥118 (corresponding to 6-month death >6%) OR
- •≥90 but <118 (corresponding to 6-month death >3% but <6%)
- •If GRACE 2.0 score ≥90 or <118 must have at least one additional high risk feature:
- •Anterior location of ECG changes (leads V2 - V5)
- •ST-segment depression in 2 contiguous leads (any territory) of 0.15mV/ 1.5mm.
- •Diabetes Mellitus on medication
- •High-sensitivity Troponin I or T 3 x ULN
- •Onset of ischaemic symptoms at any time prior to admission but most recent episode within 12 hours to admission
- •Intention to perform angiography and, if indicated, follow-on revascularisation
- •Provision of assent or written consent
- •Randomisation must be performed within 6 hours of admission
排除标准
- •ST elevation myocardial infarction
- •Evident type 2 myocardial infarction (e.g. anaemia)
- •Evidence of previous known cardiomyopathy
- •Cardiogenic Shock
- •Known severe valvular heart disease
- •Need for urgent PCI according to ESC Guidelines (haemodynamic instability, VT, VF, recurrent or persistent pain)
- •Any contraindication to PCI
- •Current participation in another intervention trial
结局指标
主要结局
Major adverse cardiovascular events
时间窗: 12 months
Incidence of the composite of all-cause mortality, new myocardial infarction and admission for heart failure within 12 months following randomisation
次要结局
- New myocardial infarction(12 months)
- Major bleeding prior to planned coronary angiography(During index admission)
- Proportion of patients needing emergency/urgent revascularisation(3-4 days (standard of care timing angiography will vary between recruiting centres))
- Total access site complications(12 months)
- Cardiovascular mortality(12 months)
- Stroke(12 months)
- Major access site complications(12 months)
- Sensitivity and specificity of novel biomarkers for predicting need for revascularisation(3-4 days (standard of care timing angiography will vary between recruiting centres))
- All-cause mortality(12 months)
- Heart failure(12 months)
- All-cause mortality prior to planned coronary angiography(During index admission)
- Admission for any cause(12 months)
- BARC 3-5 bleeding(12 months)
- Admission for ischaemia-driven revascularisation(12 months)
- Quality of life measured using Seattle Angina Questionnaire(12 months)
- Cost effectiveness(12 months)
- Left ventricular ejection fraction on cardiac MRI(7 days (+/-3 days))
- Length of in-patient stay(Through study completion, 3 years)
- New myocardial infarction prior to planned coronary angiography(During index admission)
- Quality of life measured using EuroQoL-5D-5L questionnaire(12 months)
- Infarct size on cardiac MRI(7 days (+/-3 days))