Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)
研究概览
简要总结
This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before being taken to the catheter laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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 presenting with symptoms (onset of symptoms ≤ 12 hours) of a suspected acute coronary syndrome (unstable angina or MI without persistent ST elevation) characterised as follows
- •Clinical history consistent with ongoing ischaemic chest pain and/or symptoms AND
- •>1mm ST depression AND/OR ≥2mm T wave inversion in at least two adjacent ECG leads Pathological T wave inversion in leads 1+4 suggesting 'LAD Syndrome' Or Ischaemic ST depression/T wave inversion not fulfilling the above criteria that is felt in the opinion of the attending physician to represent an acute coronary syndrome. AND
- •Written informed consent Main
排除标准
- •≤ 18 years of age
- •Previous Coronary Artery Bypass Grafting surgery
- •ST elevation myocardial infarction
- •Left bundle branch block (LBBB)
- •ST depression seen in patients during paced mode only
- •Heart rate ≥ 150bpm
- •Cardiogenic shock or other catastrophic state
- •If in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity
- •Patient participating in another clinical trial such that randomisation to DANCE would result in deviation from the protocol stipulations of either trial.
研究组 & 干预措施
Conventional Group
Patients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- Percutaneous Coronary Intervention PCI between 24 to 48 hours from randomisation according to local policy and guidelines
干预措施: Conventional Management (Procedure)
Immediate Invasive Group
Patients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting Percutaneous Coronary Intervention(PCI) will be performed according to local policy and guidelines
干预措施: Immediate Invasive Management (Procedure)
结局指标
主要结局
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)
时间窗: 12 months (duration of study)
次要结局
- The extent of myocardial damage will be evaluated using the area under the curve (AUC) for release of cardiac markers Creatinine Kinase Myocardial Band(CKMB) and troponin(within 7 days)
- Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days(at 30 days)
- Stroke at 30 days(at 30 days)
- Unplanned hospital stay (>72 hours)(within 72 hours)
- Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours(within 72 hours)
- Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours(within 72 hours)
- Additional unplanned revascularisation at 30 days.(at 30 days)
- Death at 30 days(at 30 days)
- Major bleeding(30 days)