Acute Ischemic StrokeDAYLIGHTNCT05522244
The Extended CTA for the Successful Screening of Cardioaortic Thrombus in Acute Ischemic Stroke and TIA (DAYLIGHT) Trial
A study testing extended CTA in people with Acute Ischemic Stroke and Transient Ischemic Attack, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Transient Ischemic Attack, Intracardiac Thrombus
- What is being tested?
- extended CTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2023to 27 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The ExtendeD Computed tomogrAphy angiographY for the successfuL screenInG of Cardioaortic tHrombus in Acute Ischemic Stroke and TIA (DAYLIGHT) Trial
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.
Read the detailed description
Between 16% and 25% of patients with ischemic strokes do not have an identifiable cause after a full stroke workup, and their strokes are classified as cryptogenic. 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 cardioaortic 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 transthoracic echocardiography (TTE). However, the sensitivity of TTE for detecting LV thrombi is as low as 35% without contrast and 64% with proper ultrasound contrast. Furthermore, the sensitivity for LAA thrombi is zero, given that the LAA cannot be visualized on a TTE. Transesophageal echocardiography (TEE) is a better alternative in terms of sensitivity for LV thrombus detection. 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 computer tomography (CT) angiography (CTA) of the neck and intracranial vessels. This standard of care CTA (sCTA) classically includes the aortic arch and the higher portion of the ascending/descending aorta, 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 atrial fibrillation (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.
Demonstrating that performing an eCTA can significantly increase the detection of LAA thrombi compared to sCTA has three important implications with the potential to improve clinical practice, patients' outcomes, and clinical guidelines. Furthermore, an eCTA could become part of the standard of care workup of patients presenting to the Emergency Department with a hyperacute ischemic stroke. Proving that eCTA increases the detection of cardio-aortic thrombi in stroke patients in a randomized controlled trial (highest level of evidence) may result in the recommendation of this approach in future guidelines. The increased detection of LAA thrombi may increase the use of oral anticoagulants, which have proven efficacy for the prevention of recurrent strokes in patients with cardiac thrombi, ultimately resulting in fewer stroke recurrences.10 However, proving the latter concept would require a larger randomized clinical trial with stroke recurrence as the primary efficacy endpoint. The LAA is the most frequent source of thromboembolism in patients with AF11 and LAA thrombi are associated with increased detection of AF on cardiac rhythm monitoring, implying that finding an LAA thrombus may help improve the selection of patients who could benefit from prolonged cardiac monitoring after stroke.
- Being tested
- extended CTA
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended CTADiagnostic test
Extending the standard CTA 6 cm below the carina.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: extended CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The proportion of participants diagnosed with a cardio-aortic embolic source that has an available guideline-supported treatment including thrombi, vegetations, and tumors. This outcome does not include other cardio-aortic embolic sources with a guideline-supported treatment that are primarily detected by TTE (part of the standard of care workup in stroke patients) such as high-risk PFO in young patients, acute anterior myocardial infarction with reduced ejection and no LV thrombus fraction (American Heart Association -AHA Guidelines)14, severe LV dysfunction with ejection fraction ≤35%, without evidence of LA or LV thrombus in (Canadian Secondary Prevention Best Practice Recommendations).
Measured: 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.
The proportion of participants diagnosed with a cardio-aortic embolic source known to increase the risk of stroke. This category includes the following cardio-aortic embolic sources:
- Any of the components of the primary efficacy outcome.
- Non-thrombotic slow LAA flow (SLAAF)
- Moderately to severely enlarged LA (≥42 ml/m2).
- Reduced LV ejection fraction <35%.
- High-risk PFO (either a mobile/aneurysmal atrial septum or ≥20-bubble right-to-left shunt) in individuals ≤60 years of age or in older individuals with evidence of venous thromboembolism (pulmonary embolism or deep vein thrombosis).
- Apical aneurysm/hypokinesis/akinesis, anterior wall hypokinesis/akinesis, or global hypokinesis/akinesis.
- High-risk aortic plaque defined as >4 mm thickness
- Aortic dissection involving the aortic arch, ascending, or descending26 aorta.
Measured: 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.
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, including anticoagulation, antibiotic therapy for infective endocarditis, completed or planned surgery for vegetations in infective endocarditis or aortic dissection, statin therapy in the presence of severe aortic plaque, etc. Initiation of a new therapy will be defined as a treatment started after the stroke, which the participant was not receiving before the stroke occurrence.
Measured: After having complete the standard of care stroke workup for the qualifying stroke or TIA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start17 Jul 2023
- Primary completion25 May 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano Sposato, MD, Principal investigator, London Health Sciences Center, Western UniversityRodrigo Bagur, MD, Principal investigator, London Health Sciences Center, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522244
- Sponsor's protocol ID
- 121385
- Acronym
- DAYLIGHT
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40409313Sposato LA, Ayan D, Ahmed M, Fridman S, Mandzia JL, Lodol FF, Elrayes M, Pandey S, Bagur R. Extended Computed Tomography Angiography for the Successful Diagnosis of Cardioaortic Thrombus in Acute Ischemic Stroke and TIA: Study Protocol for a Randomized Controlled Trial. Cerebrovasc Dis. 2025;54(3):415-424. doi: 10.1159/000540034. Epub 2024 Jun 26.
PubMed 38934129
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ExtendeD Computed tomogrAphy angiographY for the successfuL screenInG of Cardioaortic tHrombus in Acute Ischemic Stroke and TIA (DAYLIGHT) Trial
- ClinicalTrials.gov ID
- NCT05522244
- Acronym / sponsor ID
- DAYLIGHT / 121385
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Between 16% and 25% of patients with ischemic strokes do not have an identifiable cause after a full stroke workup, and their strokes are classified as cryptogenic. 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 cardioaortic 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 transthoracic echocardiography (TTE). However, the sensitivity of TTE for detecting LV thrombi is as low as 35% without contrast and 64% with proper ultrasound contrast. Furthermore, the sensitivity for LAA thrombi is zero, given that the LAA cannot be visualized on a TTE. Transesophageal echocardiography (TEE) is a better alternative in terms of sensitivity for LV thrombus detection. 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 computer tomography (CT) angiography (CTA) of the neck and intracranial vessels. This standard of care CTA (sCTA) classically includes the aortic arch and the higher portion of the ascending/descending aorta, 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 atrial fibrillation (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.
Demonstrating that performing an eCTA can significantly increase the detection of LAA thrombi compared to sCTA has three important implications with the potential to improve clinical practice, patients' outcomes, and clinical guidelines. Furthermore, an eCTA could become part of the standard of care workup of patients presenting to the Emergency Department with a hyperacute ischemic stroke. Proving that eCTA increases the detection of cardio-aortic thrombi in stroke patients in a randomized controlled trial (highest level of evidence) may result in the recommendation of this approach in future guidelines. The increased detection of LAA thrombi may increase the use of oral anticoagulants, which have proven efficacy for the prevention of recurrent strokes in patients with cardiac thrombi, ultimately resulting in fewer stroke recurrences.10 However, proving the latter concept would require a larger randomized clinical trial with stroke recurrence as the primary efficacy endpoint. The LAA is the most frequent source of thromboembolism in patients with AF11 and LAA thrombi are associated with increased detection of AF on cardiac rhythm monitoring, implying that finding an LAA thrombus may help improve the selection of patients who could benefit from prolonged cardiac monitoring after stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard CTA | No intervention | –Standard CTA performed as standard of care for Stroke Workup |
| extended CTA | Experimental | Diagnostic Test: extended CTAThe standard CTA will be extended 6 cm below the carina |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended CTAExtending the standard CTA 6 cm below the carina. | Diagnostic test | extended CTA |
Primary outcome
Primary Efficacy Outcome: The proportion of participants with a confirmed or "highly suspected" newly diagnosed cardioaortic thrombus
Time frame: After having complete the standard of care stroke workup for the qualifying stroke or TIA.
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.
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: After having complete the standard of care stroke workup for the qualifying stroke or TIA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 40409313Sposato 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.
- Derived from this study: PubMed 38934129Sposato LA, Ayan D, Ahmed M, Fridman S, Mandzia JL, Lodol FF, Elrayes M, Pandey S, Bagur R. Extended Computed Tomography Angiography for the Successful Diagnosis of Cardioaortic Thrombus in Acute Ischemic Stroke and TIA: Study Protocol for a Randomized Controlled Trial. Cerebrovasc Dis. 2025;54(3):415-424. doi: 10.1159/000540034. Epub 2024 Jun 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Sposato, MD principal investigator
London Health Sciences Center, Western University
Rodrigo Bagur, MD principal investigator
London Health Sciences Center, Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended CTA in people with Acute Ischemic Stroke and Transient Ischemic Attack, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Outcome: The proportion of participants with a confirmed or "highly suspected" newly diagnosed cardioaortic thrombus (time frame: After having complete the standard of care stroke workup for the qualifying stroke or TIA.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05522244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.