Exploring the Utility of Non-Invasive Coronary Angiography in Suspected Acute Coronary Syndromes with Low Level Troponin Elevation. (EN-ACT): A national study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: The intervention is an alternate anatomical assessment of the coronary arteries via computer tomography coronary angiography (CTCA) for the low‐intermediate risk participant based on high sensitivity troponin sampling. CTCA will be be performed as soon as feasible from randomisation, which be conducted routinely (and for which standard procedural consent will occur). The results of the CTCA will routinely be available to doctors/clinical care team for review, with guidance provided to the treating team regarding subsequent revascularisation based on CTCA findings. Care however will be ultimately at clinician discretion. The whole CTCA procedure including the preparatory work should take approx. 2 hours for a regular patient (the scan itself should take about 15‐20min). However it may take additional hour if the patient is having difficulties with the heart rate control. The patient's doctor /clinical care team would be the one ensuring that the participant adheres to the intervention. The research team would work closely with doctors/clinical care team to ensure the strategies are implemented as well as appropriate study arrangements are followed. CONDITION: Acute Coronary Syndromes; ; Acute Coronary Syndromes Cardiovascular ‐ Coronary heart disease PRIMARY OUTCOME: ‐Cardiovascular mortality Data will be acquired by through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public hospital admissions and care through systems such as EDDC, CRR, HIP, CLIP, ISSAC and EPAS/Sunrise (or other electronic medical records systems). Births, Deaths and Marriages and the National Death Index will be used to collect mortality and cause of death data for all participants.[Measured as the time from hospital admission to the first event.] ‐New/recurrent Myocardial Infarction (MI) consistent with the current 4th Universal Definition of MI. Data will be acquired by through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public hospital admissions and care through systems such as EDDC, CRR, HIP, CLIP, ISSAC and EPAS/Sunrise (or other electronic medical records systems). Births, Deaths and Marriages and the National Death Index will be used to collect mortality and cause of death data for all participant[Measured as the time from hospital admission to the first event.] ‐Unplanned coronary revascularisation Data will be acquired by through the SA Health data infrastructure for all SA residents. This data will be obtained by data linkage of public hospital admissions and care through systems such as EDDC, CRR, HIP, CLIP, ISSAC and EPAS/Sunrise (or other electronic medical records systems). Births, Deaths and Marriages and the National Death Index will be used to collect mortality and cause of death data for all participants.[Measured as the time from hospital admission to the first event.] INCLUSION CRITERIA: Patients presenting to the emergency department will be considered eligible for analysis if they meet all of the following: a) Age of 18 years or older b) Presenting with symptoms suggestive of ACS; c) Troponin elevation above the 99th percentile URL but less than 5 XURL d) Willing and able to give written informed consent. SECONDARY OUTCOME: ‐ All cause death All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, and 12 months post inde Xpresentation.] ‐ Health service resource utilisation, total length of stay, coronary care length of stay, time to investigations (this is one combined outcome) All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[Continually assessed throughout the recruitment period. Measured by economic analysis: 1) a within‐trial cost effectiveness analysis (i.e. comparing the observed costs and quality adjusted life years (QALYs) of the intervention and control groups during the trial period), 2) an analysis of the long‐term cost effectiveness of CTCA, adapting an existing decision analytic model.] ‐ Proportion of patients prescribed ACS therapies at discharge All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, and 12 months post inde Xpresentation.] ‐ Proportion of patients receiving coronary revascularisation during inde Xhospitalisation All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, and 12 months post inde Xpresentation.] ‐ Proportion of patients receiving ICA during inde Xhospitalisation. All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, and 12 months post inde Xpresentation.] ‐ Representation with suspected ACS within 12‐months All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, and 12 months post inde Xpresentation.] ‐Acute myocardial injury (MI) consistent with the latest Universal Definition of MI. All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, and 12 months post inde Xpresentation.] ‐Chronic myocardial injury (MI) consistent with the latest Universal Definition of MI. All data for in‐hospital care will be obtained by data linkage of public hospital admissions and care through electronic medical records systems and linkage to national databases (e.g. NDI, MBS/PBS). Where required, paper medical records will be sought.[30 days, 6 months and 12 months post inde Xpresentation.] Health‐related quality of life (EQ‐5D). This data will be obtained through telephone or mail‐out follow up.[30 days, 6 months and 12 months post inde Xpresentation.]
Epistemonikos ID: b098f7d13cb50758afa8e89c95b79f200454b9ec
First added on: Aug 26, 2024