CompletedNot Applicable

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

Canada830 participantsStarted 2023-07-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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 th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT05522244

SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-25

View on ClinicalTrials.gov More Acute Ischemic Stroke trials