RecruitingACTRN12622001316796

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

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

Sponsor

Flinders University

Enrollment

3,000 participants

Start Date

Dec 15, 2023

Study Type

Interventional

Conditions

Acute Coronary Syndromes

Summary

High sensitivity troponin assays have led to increased numbers of patients presented to the emergency department (ED) for suspected acute coronary syndrome (ACS) now having detectable troponin levels. For those with low level troponin elevated, there is limited evidence to guide care. It is suggested that individuals in this zone, have a higher risk of poor outcomes and the risk versus benefit of invasive coronary angiography (ICA) is less clear as the likelihood of an evolving heart attack is lower. Computed tomography coronary angiography (CTCA), being a less invasive alternate approach, may provide useful information to inform subsequent care to these lower risk patients. This randomised clinical trial aims to investigate CTCA vs. ICA in suspected ACS with low level troponin elevations in the ED. Outcomes will be assessed at 30 day, 6 months and 12 months.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When people come to the emergency department with chest pain and a mildly elevated blood marker called troponin, it can be hard to know if they are having a heart attack or if there is another cause. This study is comparing two ways of investigating these patients: a traditional invasive angiogram (a procedure where a tube is inserted into the body to look at heart arteries) versus a CT scan of the heart arteries, which is non-invasive and carries fewer risks. The aim is to see whether the CT approach provides enough useful information to guide treatment while being safer and less burdensome for patients with lower-risk presentations. Participants will be followed up at 30 days, 6 months, and 12 months to compare outcomes between the two groups. You may be eligible if you are 18 or older, came to an emergency department with symptoms suggesting a possible heart attack, have a mildly elevated troponin level, and do not have ongoing chest pain. People with known heart artery disease, severe kidney problems, atrial fibrillation, contrast allergies, or pregnancy are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.