None listed
Conditions
Brief summary
While invasive coronary angiography (ICA) remains one of the most commonly performed procedures in Australia, currently exceeding >100,000 admissions per annum, we have demonstrated >7-fold geographic variation in its use, and only ~27% of these procedures are performed in the context of its core indication of type 1 myocardial infarction (T1MI). Compared with other similar OECD countries, ICA use in Australia is high despite comparable rates of ACS, suggesting that the “appropriateness” of ICA use is sub-optimal in Australian clinical practice. Appropriateness of care depends on three “sufficient” conditions: 1. The patient needs to be at sufficient risk of specific clinical events to warrant the treatment; 2. The treatment must be of sufficient efficacy in reducing relevant events; and 3. The treatment strategy must be of sufficient value to the patient (i.e. absolute benefits versus side-effects, complications and economic costs) Anatomical investigation of the coronary arteries is of proven benefit in directing care and improving outcome in T1MI, but the appropriateness of such investigations in type 2 myocardial infarction (T2MI) and myocardial injury, where there is high risk of cardiac mortality and high competing risk of death from other causes, is unknown. As such, clinical equipoise remains. To date, few studies formally integrating risk assessment into the strategy of coronary investigation and management have been undertaken. A randomised trial of routine early angiography versus conservative management that carefully evaluates baseline patient risks and competing risks, is critical to the development of robust recommendations for these common high morbidity and mortality patients. This study will comprehensively evaluate the clinical impact, and economic value of early anatomic coronary investigation in T2MI and myocardial injury within a pragmatic multi-centre randomised clinical trial.
Interventions
Type 2 Myocardial Infarction (T2MI) and myocardial injury patients will be assessed for eligibility, consented appropriately and then randomised to one of two treatment arms.
Arm 1 (intervention arm) -
Those randomly allocated to arm 1 will receive routine invasive angiography within 5 days of randomisation*. The technique of angiography will be as per local practice; radial or femoral access will be permitted and revascularisation will be at the discretion of the treating team. CT angiography
Type 2 Myocardial Infarction (T2MI) and myocardial injury patients will be assessed for eligibility, consented appropriately and then randomised to one of two treatment arms. Arm 1 (intervention arm) - Those randomly allocated to arm 1 will receive routine invasive angiography within 5 days of randomisation*. The technique of angiography will be as per local practice; radial or femoral access will be permitted and revascularisation will be at the discretion of the treating team. CT angiography may be considered as an alternative to invasive angiography but must be undertaken within 5 days of randomisation*. *Angiography undertaken outside the 5-day window will be considered a protocol violation however these patients will be retained in analysis. Adherence will be monitored through review of medical records.
Sponsors
Prof Derek Chew
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed