Extended CTA for Ischemic Stroke Detection

(DAYLIGHT Trial)

Overseen By Diana Ayan, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Allergy to contrast, Pregnancy, Renal disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for detecting hidden blood clots that might cause strokes. It compares a standard CT scan (a type of X-ray) with an "extended" CT scan, known as extended CTA (computed tomography angiography), which examines the heart area more thoroughly. People who have had a stroke or a warning stroke (TIA) and are visiting the emergency department may be suitable candidates. The goal is to determine if the extended scan can better detect these clots, potentially reducing the risk of further strokes. As an unphased trial, this study allows patients to contribute to innovative research that could enhance stroke prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this extended CTA is safe for ischemic stroke detection?

Research has shown that extended CT angiography (CTA) effectively detects blood clots near the heart without slowing the CT scan process. Studies have found that this extended scan identifies more blood clots than the standard method. Importantly, this technique has not been linked to harmful side effects or major risks for patients. This suggests that extended CTA is safe and well-tolerated for people experiencing a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the extended CTA technique for ischemic stroke detection because it offers a more comprehensive view of blood flow in the brain. Unlike standard CT angiography (CTA), which only captures images up to a certain point, the extended CTA goes 6 cm below the carina, potentially revealing blockages or issues that standard CTA might miss. This could lead to earlier and more accurate detection of strokes, allowing for faster and more targeted treatment. By enhancing the detail and scope of imaging, extended CTA could significantly improve outcomes for stroke patients.

What evidence suggests that extended CTA is effective for ischemic stroke detection?

Research shows that extended CT angiography (eCTA), which participants in this trial may receive, can more effectively detect blood clots in the heart, particularly in the left atrial appendage (LAA). A recent study found that eCTA detected LAA blood clots in 6.6% of patients who had a stroke and 15% of those with atrial fibrillation (an irregular heartbeat). This detection rate is much higher compared to traditional methods like transesophageal echocardiography (TEE), which usually find clots in only 0.5% to 4.8% of cases. These findings suggest that eCTA might better identify potential sources of future strokes, aiding in the management and reduction of stroke recurrence risk in patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Rodrigo Bagur, MD

Principal Investigator

London Health Sciences Center, Western University

Luciano Sposato, MD

Principal Investigator

London Health Sciences Center, Western University

Are You a Good Fit for This Trial?

The DAYLIGHT trial is for adults who come to the emergency department or stroke clinic with a suspected stroke or mini-stroke. They don't need a confirmed diagnosis to join. However, pregnant individuals, those with severe kidney disease, past or active cancers of the head, neck, or chest; allergies to iodine-based contrast agents; or without vein access for IV contrast are excluded.

Inclusion Criteria

I may not have had a stroke or TIA to join, but need one confirmed for certain study parts.

I am an adult being checked for a stroke at University Hospital in London, Ontario.

Exclusion Criteria

I don't have conditions that prevent me from having a CTA scan for stroke.

Allergy to iodinated contrast agents

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either standard CTA or extended CTA as part of the stroke workup

1 year

Regular visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Optional extended monitoring for participants with detected cardioaortic thrombi

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• extended CTA

Trial Overview This study tests if an extended CT angiography (eCTA) can better detect blood clots in the heart's left atrial appendage compared to standard CT angiography (sCTA). Both groups will receive usual care for stroke evaluation but one group will have additional imaging extending below the carina.

How Is the Trial Designed?

Group I: extended CTA Experimental Treatment 1 Intervention

The standard CTA will be extended 6 cm below the carina

Group II: standard CTA Active Control 1 Intervention

Standard CTA performed as standard of care for Stroke Workup

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Published Research Related to This Trial

Modern multi-slice computed tomography (MSCT) is now the preferred method for quickly evaluating neurological emergencies due to its rapid examination times and broad availability.

MSCT angiography is increasingly replacing traditional diagnostic digital subtraction angiography (DSA) for assessing conditions like intracranial aneurysms and acute strokes, enhancing detection rates and potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neurologic emergencies and multislice computed tomography]. Eftimov, L., Morhard, D., Reiser, M., et al.[2021]

In a study of 1097 patients undergoing non-coronary cardiac CT angiography (CTA), the most common reason for the procedure was to evaluate pulmonary vein anatomy, highlighting its importance in cardiac assessments.

The procedure demonstrated a very low complication rate of 1.5% and provided new clinical diagnostic information in 3.2% of cases, indicating its safety and potential to uncover important health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic report on non-coronary cardiac CTA in 1097 patients from the German cardiac CT registry. Gitsioudis, G., Marwan, M., Schneider, S., et al.[2021]

In a study of 50 patients treated with thrombolytic therapy for hyperacute stroke, advanced imaging techniques like CT, CTA, and perfusion CT were found to be more effective in identifying ischemic areas and salvageable brain tissue compared to routine non-contrast CT.

The use of advanced CT imaging allowed for better patient triage for thrombolysis, leading to clinical improvement in 58% of patients, with a low complication rate of only 4% experiencing subsequent bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging impact of CTA/perfusion CT on acute stroke thrombolysis in a community hospital. Brant-Zawadzki, MN., Brown, DM., Whitaker, LA., et al.[2019]

In a study of 120 patients with CT-confirmed or suspected intracranial hemorrhage, cerebral computed tomography angiography (CTA) revealed abnormalities in 42% of cases, including aneurysms in 27% and arteriovenous malformations (AVM) in 8%.

Despite its diagnostic value, over half (58%) of the patients had normal CTA results or findings unrelated to the hemorrhage, highlighting the need for careful clinical judgment to weigh the risks of radiation exposure and intravenous contrast against the potential benefits of the CTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of computed tomography angiogram in intracranial hemorrhage. Do the benefits justify the known risks in everyday practice? Alshumrani, G., Al Abo Nasser, B., Alzawani, A., et al.[2021]

A systematic review and meta-analysis of 4 studies indicated that contrast extravasation on CT angiography is strongly associated with a higher risk of hematoma expansion in traumatic brain injury, with a relative risk of 5.75.

Contrast extravasation was also linked to worse neurological outcomes and increased mortality, with relative risks of 3.25 and 2.77, respectively, highlighting its importance as a predictive imaging sign in TBI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The extravasation of contrast as a predictor of cerebral hemorrhagic contusion expansion, poor neurological outcome and mortality after traumatic brain injury: A systematic review and meta-analysis. Baldon, IV., Amorim, AC., Santana, LM., et al.[2020]

In a study of 918 patients with acute ischemic stroke, those who received iodinated contrast agents during CT imaging had a lower incidence of acute nephropathy (AN) at 5% compared to 10% in those who did not receive contrast, suggesting that contrast use may not be as risky as previously thought.

Patients who underwent conventional angiography after contrast-enhanced CT did not show a higher risk of acute nephropathy compared to those who only had the CT imaging, indicating that the use of contrast in these procedures is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional contrast-enhanced CT for evaluation of acute ischemic stroke does not increase the risk of contrast-induced nephropathy. Lima, FO., Lev, MH., Levy, RA., et al.[2021]

Cardiac and large artery sources are major contributors to acute ischemic stroke, highlighting the need for effective evaluation methods.

Using advanced CT angiography (CTA) for early assessment of these patients can enhance management and outcomes while potentially reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of cardiac and extracranial vascular CT in the evaluation/management of cerebral ischemia and stroke. Kamalian, S., Kamalian, S., Pomerantz, SR., et al.[2021]

In a study of 27 patients with acute subarachnoid hemorrhage, combining perfusion CT (PCT) with CT angiography (CTA) proved to be a highly accurate method for diagnosing vasospasm, achieving an accuracy of 93% when using mean transit time (MTT) thresholds.

PCT demonstrated a higher positive predictive value (89.9%) for identifying vasospasm compared to transcranial Doppler (TCD) ultrasonography (62.9%), suggesting that PCT may be a more reliable tool for guiding treatment decisions in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasospasm after subarachnoid hemorrhage: utility of perfusion CT and CT angiography on diagnosis and management. Wintermark, M., Ko, NU., Smith, WS., et al.[2022]

In a study of 266 patients with embolic stroke of undetermined source (ESUS), cardiac computed tomography angiography (CCTA) detected intra-cardiac thrombi in 17% of those who underwent the procedure, which could significantly influence treatment decisions.

CCTA identified 22 patients (8.2% of the entire ESUS cohort) with thrombi that were otherwise missed by standard echocardiography, suggesting that incorporating CCTA into routine ESUS workup can enhance secondary prevention strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac CT for intra-cardiac thrombus detection in embolic stroke of undetermined source (ESUS). Barnea, R., Agmon, IN., Shafir, G., et al.[2022]

The cerebral collateral circulation is crucial for preserving brain tissue at risk during an ischemic stroke, and its assessment through computed tomography angiography (CTA) can guide treatment decisions.

Multi-phase CTA (mCTA) is found to be superior to single-phase CTA (sCTA) in evaluating collateral circulation, making it a promising tool for identifying patients with acute ischemic stroke who may benefit from reperfusion therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal role of multiphase computed tomography angiography for collateral assessment in patients with acute ischemic stroke. Busto, G., Morotti, A., Carlesi, E., et al.[2023]

In a study of 56 patients with primary intracerebral hemorrhage (ICH), active contrast extravasation observed on CT scans was found to independently predict both increased mortality and hematoma growth.

The presence of contrast extravasation was significant in multivariate analyses, indicating that it is a reliable predictor of poor outcomes in ICH patients, alongside factors like initial hematoma size and clinical scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast extravasation on CT predicts mortality in primary intracerebral hemorrhage. Kim, J., Smith, A., Hemphill, JC., et al.[2022]

In a study of 54 patients with acute neurological deficits, combining CT angiography (CTA) results with the NIH Stroke Scale improved the specificity for predicting clinical outcomes, especially in cases with no arterial occlusion.

Knowledge of CTA results sometimes led to more conservative treatment decisions for thrombolysis, indicating that while CTA can enhance decision-making, it may also result in less aggressive interventions in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of CT angiography in acute ischemic stroke. Verro, P., Tanenbaum, LN., Borden, N., et al.[2016]

In a study of 85 stroke patients, performing CT angiography (CTA) before perfusion CT (PCT) did not significantly affect the quantitative perfusion parameters, indicating that the order of these tests may not impact the diagnostic quality.

However, conducting CTA before PCT resulted in significantly shorter examination times, which is crucial for timely treatment in stroke patients, while also avoiding issues with venous contrast enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal sequence timing of CT angiography and perfusion CT in patients with stroke. Morhard, D., Wirth, CD., Reiser, MF., et al.[2019]

A systematic review of 12 studies involving 17,481 patients found that computed tomography angiography (CTA) did not significantly improve outcomes such as recurrent stroke, mortality, or disability compared to other imaging methods in ischemic stroke and transient ischemic attacks (TIAs).

The quality of evidence regarding the effectiveness of CTA was rated as low to very low, indicating a need for more high-quality research to determine its true impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Outcomes With Use of Computed Tomography Angiography in Acute Ischemic Stroke and Transient Ischemic Attack: A Systematic Review and Meta-Analysis. Li, SS., Trajkovski, A., Siarkowski, M., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05522244

Study Details | NCT05522244 | The Extended CTA for the ... 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 ...

2. karger.com karger.com/ced/article/54/3/415/909747/Extended-Computed-Tomography-Angiography-for-the

Extended Computed Tomography Angiography for the ... Recent evidence from retrospective observational studies has shown a high detection of cardiac thrombi, ranging from 6.6 to 17.4%, by extending ...

3. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(25)00111-5/abstract

Extended CT angiography versus standard ... Performing extended CT angiography during acute code strokes is feasible and results in increased cardioaortic thrombi detection without causing delays in CT ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38934129/

Study Protocol for a Randomized Controlled Trial The DAYLIGHT trial will provide evidence on whether extending a CTA to include the heart results in an increased detection of cardioaortic thrombi.

5. withpower.com withpower.com/trial/phase-ischemia-9-2022-840e8

Extended CTA for Ischemic Stroke Detection (DAYLIGHT ... Trial Overview This study tests if an extended CT angiography (eCTA) can better detect blood clots in the heart's left atrial appendage compared to standard CT ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442225001115

Extended CT angiography versus standard ... Performing extended CT angiography during acute code strokes is feasible and results in increased cardioaortic thrombi detection without causing delays in CT ...