Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NON-ST-Elevation Myocardial Infarction=NONSTEMI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Patients with acute myocardial infarction (AMI) are categorized according to the electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3) remaining patients with so-called NON-ST-Elevation Myocardial Infarction (NONSTEMI).
Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers with PPCI facilities is recommended.
In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72 hours of symptom onset, is associated with improved outcome when compared to late angioplasty or conservative therapy. No trials have so far been able to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at a hospital, and triage them directly to PPCI. Implementation of point-of-care (POC) testing of biomarkers may enable prehospital or early inhospital establishment of the diagnosis NONSTEMI.
The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c) ECG findings and then randomize patients to I) PPCI, or II) medical therapy and angiography/angioplasty within 72 hours (todays routine).
Se below for detailed description
详细描述
In the present trial patients with a) typical angina pectoris (AP) combined with b1) rise in biomarkers on POC testing (prehospital/immediately inhospital) and/or b2) ST-segment depression of more than 0.2 mV in two contiguous leads or more than 0.1 mV in four contiguous leads are randomized to I) PPCI (same protocol as in STEMI patients) or II) medical therapy and angiography/angioplasty within 72 hours (todays routine practice).
The primary purposes of the present trial is threefold:
- To evaluate if it is possible to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at the hospital (N=250 patients)
- To compare a combined endpoint of mortality, re-infarction (during index admission or readmitted), or readmission with Congestive Heart Failure (CHF) between group I (PPCI strategy) and group II (routine strategy) (N=2500 patients).
- To compare mortality between group I and II (N=4500 patients).
Secondary purposes of the present trial is:
- To evaluate whether there is difference in the primary endpoints in patients randomized within or after 12 hours of symptom onset.
- To evaluate whether there is difference in the primary endpoints in patients randomized in the prehospital phase and on admission to the hospital, respectively.
- To evaluate whether there is difference in the primary endpoints in patients with a final diagnosis of AMI, as adjudicated by a clinical event committee.
- To evaluate whether there is difference in the primary endpoints in patients with or without diabetes, respectively.
- To compare a combined endpoint of mortality, readmission with AMI, readmission with CHF, readmission with AP, revascularization (not planned on index admission).
- To compare a combined safety endpoint of stroke or serious bleeding between group I and II.
- To evaluate if there is difference in the frequency of PCI and CABG in group I versus II.
- To compare total admission time between group I and II.
- To compare total cost between group I and II.
- To compare total duration where the patient is on sick leave between group I and II
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elevated biomarkers (Point-of-care testing) either prehospital or immediately on admission
- •ST-segment depression of 0.2mV or more in two contiguous leads or 0.1 mV or more in four contiguous leads.
- •Patient can be randomized either in the prehospital phase or within 30 minutes of admission to a hospital
排除标准
- •Tachycardia > 120
- •Age < 18 or > 80 years
- •Indication for PPCI already fulfilled
- •Patient cannot understand the study information
- •Presumed "troponisme"
- •Left ventricular hypertrophy
- •Known dialysis
- •Previous CABG
- •Pregnancy
研究组 & 干预措施
Group I: PPCI
Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI
干预措施: Group I: Primary PCI (Procedure)
Conventional: Group II
Patients are treated as today: Admission to local hospital, Low-molecular-weight heparin (LMWH), Aspirin, ADP-blocker and within 72 hours transfer for angiography/angioplasty. Patients with a Grace score > 140 will be transferred for angiography/angioplasty within 24 hours. Patients with refractory angina, severe heart failure, life-threatening ventricular arrhythmias or haemodynamic instability will be transferred acutely for angiography/angioplasty according to the european guidelines.
结局指标
主要结局
Mortality
时间窗: within 1 year from randomization
all-cause mortality
Re-infarction
时间窗: within 1 year from randomization
Re-infarction (during index admission or readmitted) adjudicated by and endpoint committee. The endpoint committee is blinded to the initial randomization. The "Universal definition of Myocadial infarction" will be used to classify reinfarction. Biomarkers will be recorded with emphasis on the need of obtaining blood samples until a peak has been reached during index hospitaltization before reinfarction can be considered. Re-infarction will require a 20% relative rise in biomarker level.
Readmission with CHF
时间窗: within 1 year from randomization
Readmission or visit in the outpatient clinic with CHF. Readmission or visit with CHF needs to be adjudicated by an endpoint committee blinded to the initial randomization.
Confirmed AMI
时间窗: during index admission
An endpoint committee needs to evaluate whether each patient had AMI on the index admission. This evaluation is performed without the endpoint committee being aware whether the patient was randomized to PPCI or conventional therapy. The endpoint committee will classify whether the patient had: a) NONSTEMI, b) STEMI with symptom duration \<=12 hours, c) STEMI with symptom duration \>12 hours, d) BBBMI with symptom duration \<=12 hours or e) BBBMI with symptom duration \> 12 hours.
次要结局
- Readmission with AP(within 3 months, 1 year, and 5 year from randomization)
- Readmission with stroke(within 3 months, 1 year, and 5 year from randomization)
- Non-scheduled re-intervention(within 3 months, 1 year, and 5 year from randomization)
- Duration of index admission(Time from initial admission to discharge)
- Sick-leave from work(within 3 months, 1 year, and 5 year from randomization)
- Total cost(within 3 months, 1 year, and 5 year from randomization)
- Bleeding(within 3 months, 1 year, and 5 year from randomization)
- Time to intervention(Time from ambulance call to PCI or CABG is performed or angiography is performed without indication for PCI or CABG)
- Cardiovascular mortality(within 3 months, 1 year, and 5 year from randomization)
研究者
Christian Juhl Terkelsen
Associate professor, MD, PhD
Aarhus University Hospital Skejby