The Extended CTA for the Successful Screening of Cardioaortic Thrombus in Acute Ischemic Stroke and TIA (DAYLIGHT) Trial

NCT05522244 | Completed DMC

• 1 other identifier: 121385
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 1

Brief Summary

Embolic strokes of undetermined source (ESUS) represent a subset of cryptogenic strokes that are suspected to have an occult embolic source. The risk of stroke recurrence in patients with ESUS varies between 1.9%/year and 19.0%/year depending on the prevalence of vascular risk factors. Part of the elevated recurrence rate is due to the inability to identify high-risk treatable causes such as cardiac thrombi as those found in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), valves, or aortic arch. The most frequently used diagnostic method in clinical practice to detect cardioaortic thrombi is transesophageal echocardiography (TEE). However, the relatively low availability, higher cost, and invasive nature of TEE limit its large-scale usability. In most stroke centers, patients presenting with an acute ischemic stroke or TIA undergo a tomography (CT) angiography (CTA) of the neck and intracranial vessels. This standard of care CTA (sCTA) classically includes the aortic arch, the higher portion of the ascending/descending aorta, and the rostral portion of the cardiac chambers, but does not involve the LAA, LV, or cardiac valves. A recent study performed among 300 patients with an acute ischemic stroke showed an overall LAA thrombus detection of 6.6% and 15% in patients with AF by extending the CTA 6 cm below the carina. This is an extraordinarily high prevalence of LAA compared to 0.5% to 4.8% of intracardiac thrombi identified on TEE in most previous studies. The major limitation of previous CTA and TEE studies is their observational design, so the differing prevalence of LAA thrombi could be explained by dissimilar population characteristics or selection bias. Based on the methodological limitation of prior studies and the promising role of extended CTAs (eCTA), a randomized controlled trial comparing eCTA + standard of care stroke workup vs. sCTA + standard of care stroke workup is needed.

Conditions

Acute Ischemic Stroke; Transient Ischemic Attack; Intracardiac Thrombus

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Outcome: The proportion of participants with a confirmed or "highly suspected" newly diagnosed cardioaortic thrombus

  The proportion of participants with a confirmed of "highly suspected" newly diagnosed cardioaortic thrombus (LAA, LA, LV, aorta, any aortic branch proximal to the origin of the common carotid or vertebral arteries, valves, or any other cardiac thrombus) after having completed the standard-of-care stroke workup, regardless of a history of AF or newly detected AF. Although the eCTA is extended 6 cm below the carina to target the LAA, cardiac size and position within the mediastinum vary significantly across patients and in most cases, the eCTA will include part of the left ventricle.

  After having complete the standard of care stroke workup for the qualifying stroke or TIA.

Secondary Outcomes (3)

• Secondary Efficacy Outcome 1: The proportion of participants diagnosed with a cardio-aortic embolic source that has an available guideline-supported treatment including thrombi, vegetations, and tumors.

  After having complete the standard of care stroke workup for the qualifying stroke or TIA.

• Secondary efficacy outcome 2: The proportion of participants diagnosed with a cardio-aortic embolic source known to increase the risk of stroke.

  After having complete the standard of care stroke workup for the qualifying stroke or TIA.

• Secondary efficacy outcome 3: The proportion of participants diagnosed with a cardio-aortic embolic source resulting in the initiation of a new secondary prevention treatment other than antiplatelet therapy.

  After having complete the standard of care stroke workup for the qualifying stroke or TIA.

Other Outcomes (8)

• Tertiary efficacy outcome 1: Detection of a pulmonary nodule or mass.

  After having complete the standard of care stroke workup for the qualifying stroke or TIA.

• Tertiary efficacy outcome 2: The detection of pulmonary embolism.

  After having complete the standard of care stroke workup for the qualifying stroke or TIA.

• Tertiary efficacy outcome 3: Association between Slow LAA Flow and Cognitive Impairment in Stroke Patients.

  Through study completion, an average of 1 year

Study Arms (2)

standard CTA

NO INTERVENTION

Standard CTA performed as standard of care for Stroke Workup

extended CTA

EXPERIMENTAL

The standard CTA will be extended 6 cm below the carina

Diagnostic Test: extended CTA

Interventions

extended CTA DIAGNOSTIC_TEST

Extending the standard CTA 6 cm below the carina.

extended CTA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients with a suspected cerebrovascular event who are evaluated in the Emergency Department or the Urgent Stroke Prevention Clinic at University Hospital, London Health Sciences Centre, London, Ontario, Canada.
• A confirmed diagnosis of stroke or TIA is not mandatory for patient enrollment and randomization. However, patients without a cerebrovascular event will be further excluded from the analysis of efficacy and safety outcomes. Only patients with an adjudicated ischemic stroke or TIA will be included in the latter analyses. The same patient may be included more than once in the study in case of presenting to the hospital with a suspected stroke on different dates. These patients will be excluded only if they had an outcome event (cardioaortic thrombus) previously adjudicated in the study. The reason for including patients more than once is that the cause of the stroke or the stroke mechanism can change with time (e.g. patient with post-stroke MI developing a new LV thrombus, a patient who had a stroke due to AF who is now on anticoagulants and presents with a new contralateral stroke due to severe carotid artery stenosis).

You may not qualify if:

• Allergy to iodinated contrast agents
• Pregnancy
• Lack of a peripheral vein access for intravenous contrast administration
• Any contraindication for the clinical use of a CTA for hyperacute stroke care (e.g., end-stage renal disease that contraindicates a CTA), and active or past cancer of the head, neck, or chest)
• Patients with known or newly diagnosed AF will not be excluded.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

• Sposato LA, Ayan D, Ahmed M, Fridman S, Mandzia JL, Elrayes M, Lodol F, Khaw AV, Mai LM, Bogiatzi C, Casserly C, Fraser JA, Chan R, Florendo Cumbermack A, Markovic N, Yu Y, Debicki D, Fleming L, Beauchamp B, Lambourn L, Mayich M, Milroy L, Sharma M, Pandey S, Bagur R. Extended CT angiography versus standard CT angiography for the detection of cardioaortic thrombus in patients with ischaemic stroke and transient ischaemic attack (DAYLIGHT): a prospective, randomised, open-label, blinded end-point trial. Lancet Neurol. 2025 Jun;24(6):489-499. doi: 10.1016/S1474-4422(25)00111-5.

  PMID: 40409313 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Luciano Sposato, MD

  London Health Sciences Center, Western University

  PRINCIPAL INVESTIGATOR

• Rodrigo Bagur, MD

  London Health Sciences Center, Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 30, 2022
• Study Start: July 17, 2023
• Primary Completion: May 25, 2024
• Study Completion: November 27, 2024
• Last Updated: April 1, 2025

Record last verified: 2024-04

Locations

CA (1)