Currently submitted to: JMIR Research Protocols
Date Submitted: Jan 25, 2026
Open Peer Review Period: Jan 26, 2026 - Mar 23, 2026
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Computed Tomography Coronary Angiography Screening of Asymptomatic Patients With Chronic Limb-Threatening Ischaemia at Hospital Discharge: Protocol for a Randomised Control Trial
ABSTRACT
Background:
Chronic limb-threatening ischaemia (CLTI) is associated with high rates of cardiovascular morbidity and mortality, which may be attributable to undiagnosed coronary artery disease (CAD). Sequelae of CLTI and its common comorbidities often restrict mobility and mask typical anginal symptoms. Although observational studies suggest a high prevalence of silent, haemodynamically-significant CAD in CLTI, there is no randomised evidence supporting routine coronary screening in CLTI patients.
Objective:
This trial aims to determine whether a CT coronary angiography (CTCA)–based screening strategy improves cardiovascular outcomes compared with best medical therapy (BMT) alone in patients presenting with CLTI who are asymptomatic for CAD, who haven no prior CAD diagnosis.
Methods:
This is a prospective, multicentre, open-label, randomised controlled trial. Adults admitted under vascular surgery with CLTI, no known CAD, and no cardiac symptoms will be randomised 1:1 at or near hospital discharge to CTCA screening plus guideline-directed BMT or guideline-directed BMT alone. CTCA will be performed within 30–90 days of discharge using a standardised acquisition and reporting protocol, with optional CT-derived fractional flow reserve. Downstream cardiac management will be at the discretion of the on-call treating cardiologist. Participants will be followed for 12 months through standardised clinic follow-up appointments. The primary endpoint is time to first occurrence of non-fatal myocardial infarction or coronary heart disease death. Secondary outcomes include major adverse cardiovascular events, major adverse limb events, diagnostic yield of CTCA, changes in cardiovascular management, safety outcomes, and exploratory cost-effectiveness analyses. Analyses will be conducted on an intention-to-treat basis.
Results:
As of January 2026, the study is in the pre-recruitment phase. Trial registration with the Australian New Zealand Clinical Trials Registry has been completed. Pending ethics committee approval, recruitment is planned to commence in July 2026, with an anticipated enrolment of approximately 500 participants across participating centres.
Conclusions:
This trial will provide the first randomised evidence evaluating the clinical utility of systematic CTCA screening in patients with CLTI. Findings will inform clinical practice and guideline development regarding coronary investigation in this high-risk population. Clinical Trial: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN391034
Citation
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