The Appropriateness of Coronary investigation in myocardial injury and Type 2 myocardial infarctio

Not Applicable

Recruiting

• Conditions: Type 2 Myocardial Infarction (MI); Myocardial injury; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12618000378224
• Lead Sponsor: Prof Derek Chew

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-14
• Last Update Posted: 28 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1800

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified