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Computed Tomography Coronary Angiography Screening of Asymptomatic Patients With Chronic Limb-Threatening Ischaemia at Hospital Discharge: A Randomised Control Trial

Computed Tomography Coronary Angiography Screening of Asymptomatic Patients With Chronic Limb-Threatening Ischaemia at Hospital Discharge: A Randomised Control Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000150347
Enrollment
400
Registered
2026-02-06
Start date
2026-07-01
Completion date
2027-12-31
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic limb-threatening ischaemia (CLTI) represents the most severe form of lower-extremity peripheral artery disease. where patients present with ischaemic rest pain or ulceration/gangrene of the extremities. CLTI is associated with 1-year mortality rates exceeding 20% and 5-year mortality beyond 50–60%. Much of this excess risk is driven by concomitant but often silent coronary artery disease (CAD). Contemporary CT coronary angiography (CTCA) and CT-derived fractional flow reserve (FFR-CT) studies in CLTI cohorts without known CAD or cardiac symptoms have reported haemodynamically significant coronary ischaemia in ~70% of patients. Observational data suggest that FFR-guided revascularisation of silent CAD after lower-extremity revascularisation may markedly reduce death and myocardial infarction (MI), but current vascular and PAD guidelines do not recommend routine coronary screening in asymptomatic PAD patients. The utility of systematic CTCA screening at or shortly after hospital discharge for CLTI therefore remains uncertain. We aim to conduct a multi-centre randomised control trial within Australia of patients presenting with CLTI, with no prior history of CAD. Our primary objective will be to determine the diagnostic yield, management impact, and 12-month cardiovascular outcomes of systematic CTCA screening at discharge in patients hospitalised with CLTI who are asymptomatic for CAD and have no previous CAD diagnosis.

Interventions

Computed Tomography Coronary Angiography + Best Medical Therapy In both arms, each patient will receive an information leaflet which will be created and proofread by the panel of investigators. Arm 1: CTCA Screening + Best Medical Therapy CTCA • Performed within 90 days of hospital discharge, ideally within 30 days. • Scanner specifications: 64-slice multi-detector CT with detector element width 0.625mm with ECG-gating, following SCCT performance guidelines. • Patient preparation: o Rate co

Computed Tomography Coronary Angiography + Best Medical Therapy In both arms, each patient will receive an information leaflet which will be created and proofread by the panel of investigators. Arm 1: CTCA Screening + Best Medical Therapy CTCA • Performed within 90 days of hospital discharge, ideally within 30 days. • Scanner specifications: 64-slice multi-detector CT with detector element width 0.625mm with ECG-gating, following SCCT performance guidelines. • Patient preparation: o Rate control with oral beta-blockers targeting heart rate 100kg in accordance with 'As Low as Reasonably Achievable' (ALARA) principles of radiation safety o High-iodine contrast media of 270-400mg iodine/mL as per department protocol o Standard biphasic contrast injection protocols (50-80mL contrast media at 5-7mL/s followed by 40-50mL 0.9% sodium chloride chaser at 5-7mL/s. o Scan performed during inspiration with medium-sized breaths o Reconstructions in standard cardiac planes. o Estimated scan duration of 10-15 minutes however preparation including premedication, cannulation and collection of vital signs may take 30-60 mins. o Reporting using a structured system (e.g. Coronary Artery Disease – Reporting and Data System: CAD-RADS) including segmental stenosis severity (0–5), plaque characteristics and calcium scoring • FFR-CT: o CTCA datasets may be sent for FFR-CT analysis. o Ischaemia-producing lesions defined as FFR-CT <0.80, and severe ischaemia as FFR-CT <0.75 o Absence of FFR-CT will not constitute a protocol deviation. Post-CTCA Management • Lesion management will remain at the discretion of the on-call cardiologist • Recorded therapeutic modifications will include o Initiation or intensification of antiplatelet therapy o Initiation or intensification of lipid-lowering therapy o Initiation or optimisation of anti-hypertensive therapy or beta-blockade o Referral for invasive coronary angiography o Performance of PCI or CABG • Classification of each patient as: o No change in CAD-related management. o Medical therapy intensified only. o Referral for invasive coronary angiography o Underwent endovascular or open coronary revascularisation Best Medical Therapy (BMT) Based upon Australian clinical guidelines for management of cardiovascular disease • High-intensity statin at maximally-tolerated dose (rosuvastatin 20-40mg daily or equivalent) • Antiplatelet therapy (aspirin ± clopidogrel as per clinician) • Blood pressure optimisation, aiming for systolic blood pressure =140mmHg • Angiotensin converting enzyme (ACE) inhibitor or angiotensin-II receptor blocker (ARB), especially in patients with left ventricular ejection fraction (LVEF) <40%, symptoms of heart failure, diabetes, hypertension, and/or chronic kidney disease • Beta-blockers in patients with impaired left ventricular function • Smoking cessation programme referral • Diabetes optimisation aiming for an HbA1c =7.0% Arm 2: Best Medical Therapy Alone BMT will be consistent across both arms Coronary assessment in Arm 2 may occur only if clinically indicated • Development of new chest pain or other symptoms concerning for CAD • Unexplained dyspnoea or exercise intolerance • Preoperative evaluation if indicated prior to major surgery c) who will deliver the intervention BMT will be directed by the admitting vascular team according to the study protocol as above, with the input of other specialist medical services such as endocrinology and cardiology, CTCA will be performed within the referring institution or its tertiary referral service to ensure consistency in imaging protocol d) the mode of delivery BMT will be prescribed during inpatient admission and compliance monitored during outpatient follow up CTCA will also be organised for the patient during their admission by the vascular surgery team. e) the number of times the intervention will be delivered and over what period of time Patients will have their BMT optimised in hospital and have one postoperative CTCA. f) the location/setting where the intervention occurs The BMT prescription will be given at the admitting institution. The CTCA as stated above will be performed in the institution where the patient was admitted, or its corresponding tertiary referral unit. g) any strategies used to assess or monitor adherence or fidelity to the intervention Patients will be followed up within the department's vascular surgery outpatient clinic. Their compliance will be monitored at each visit. Following CTCA - the reports will be sent to an interventional cardiologist. We aim to recruit an interventional cardiologist to our study panel.

Sponsors

Asanka Wijetunga, Westmead Hospital Department of Vascular Surgery
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age greater than or equal to 18 years. Index admission under vascular surgery for CLTI according to current Global Vascular Guidelines (https://pmc.ncbi.nlm.nih.gov/articles/PMC8365864/#F4 - Accessed 19:09 31/12/2025) Objectively documented atherosclerotic PAD - Clinical history and examination - Ankle-brachial pressure index (ABPI) / Ankle Pressure (AP) ± toe-brachial index (TBI) / Toe Presure (TP) - Non-invasive vascular imaging modalities where the above are inconclusive / unavailable / where revascularisation is considered (duplex ultrasonography, computed tomography angiography / magnetic resonance angiography). Symptoms of - ischaemic rest pain - tissue loss (ulceration or gangrene) No known history of coronary artery disease (CAD): - No prior myocardial infarction - No prior coronary revascularisation - No prior angiographically documented >50% coronary stenosis. - No prior positive functional test or CT coronary angiography (CTCA) labelled as CAD. Asymptomatic for CAD: - No typical angina or anginal equivalent symptoms in the preceding 3 months. Able to provide written informed consent.

Exclusion criteria

• Patients not meeting criteria for diagnosis with CLTI • Patients acutely symptomatic with typical chest pain, cardiogenic shock, acute pulmonary oedema • Known CAD, history of MI, prior coronary revascularisation • Coronary angiography or CTCA prior to randomisation • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² according to current guidelines • Known severe iodinated contrast allergy not suitable for premedication. • Arrhythmias or sick sinus syndrome without a permanent pacemaker, or other contraindications to beta-blockers and nitrates (such as severe asthma or severe bronchodilator-dependent chronic obstructive pulmonary disease) precluding adequate CTCA image quality • NYHA Grade III/IV cardiac failure or decompensation of cardiac failure within 30 days of admission. • Contraindication to CTCA or to antiplatelet therapy. • Pregnancy or breastfeeding. • Life expectancy <12 months as judged by the treating team. • Participation in a competing interventional trial mandating different cardiac imaging.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026