ACTRN12618000378224招募中未知
The Appropriateness of Coronary investigation in myocardial injury and Type 2 myocardial infarction
Prof Derek Chew0 个研究点目标入组 1,800 人开始时间: 2018年3月14日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 1,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •The study will enrol in-hospital patients with at least one elevated (rule-in”) troponin result using the local laboratory standards (Troponin T or I, with test sensitivity as implemented locally) defined as either:
- •i. Troponin T (Roche Elecsys): >52ng/L
- •ii. Troponin I (Abbott Architect, Siemens Dimension Vista, Beckman Coulter Access): equal to or over 5 times the assay-specific upper limit of normal.
- •In addition, all patients must also fulfill all of the following
- •1. A clinical presentation consistent with a clear non-coronary alternative diagnosis, N.B.: In all cases medical stabilization of patient prior to angiography will be required.
- •2. Patient is 18 years of age or older; and
- •3. Patient is willing to give his/her written informed consent;
- •For trial eligibility, all patients must have an unequivocal acute intercurrent diagnosis. Specifically:
- •1. Sepsis: Clinical evidence of a fever and/or a raised white cell count plus an elevation in C-reactive protein above the local laboratories reference limit and:
- •a. Pneumonia: Cough, shortness of breath or positive sputum culture and radiological changes consistent with pneumonia on chest imaging
- •b. Urosepsis: frequency, urgency or dysuria, with leukocytes in urinalysis and positive urine microscopy and culture
- •c. Septicaemia: systemic symptoms of fevers, chills or sweats, and positive blood cultures thought not to be a contaminant.
- •d. Systemic Inflammatory Response Syndrome (SIRS): With 3 or more of:
- •i. Temperature, <36 °C (96.8 °F) or >38 °C (100.4 °F)
- •ii. Heart rate, >90 beats/min
- •iii. Respiratory rate, >20/min or PaCO2<32 mmHg
- •iv. While bleed cell count, <4x109/L, >12x109/L, or 10% bands
- •2. Anaemia: haemoglobin <10mg/dL on at least 2 samples within 48 hours
- •3. Thyrotoxicosis: TSH below the lower limit of normal
- •4. Atrial tachycardias: Evidence of sustained narrow complex tachycardia (Atrial fibrillation, atrial flutter, SVT) >120bpm for >20 min, documented on ECG monitoring. (i.e documentation of rate but not total duration of tachycardia)
- •5. Recent non-cardiac surgery, defined as surgical procedure requiring regional or general anaesthesia within 7 days of enrolment
- •6. Traumatic fractured neck of femur demonstrated on x-ray, within the prior 7 days
- •7. Acute kidney injury requiring dialysis or causing severe renal impairment (creatinine >150mmol/L) where dialysis remains a therapeutic consideration.
排除标准
- •1.Patients with clinically-defined T1MI: i.e. a rise and/or fall in troponin with at least 1 result above the 99th percentile of normal, with/without ECG changes consistent with ischaemia, and NO evidence of intercurrent illness.
- •2.Patients with ST-segment elevation on the presenting ECG
- •3.Haemodynamic instability including hypotension (Systolic BP<90mmHg, or requiring inotrope support), acute kidney injury where creatinine levels are not stable
- •4.Patients with a prior angiogram within the last 6 months, regardless of the presence or absence of documented coronary artery disease on that investigation.
- •5.New York Heart Association Class II-IV heart failure or Killip Class II-IV
- •6.Symptomatic angina with a Canadian Cardiovascular Society class II or more classification
- •7.Extensive frailty or co-morbidity in whom the treating physicians are unwilling to undertake a coronary angiogram (e.g. severe renal impairment in a patient unwilling to consider dialysis), or where life-expectancy is expected to be less than 2 years.
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