Extended CTA for Ischemic Stroke Detection
(DAYLIGHT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
Trial Summary
What is the purpose of this 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.
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 data supports the effectiveness of the treatment extended CTA for ischemic stroke detection?
Research suggests that using advanced CT techniques like CTA can help identify areas of the brain that might still be saved after a stroke, which can lead to better treatment decisions and outcomes compared to using standard CT scans alone.
12345Is extended CTA generally safe for humans?
Research indicates that using contrast-enhanced CT for evaluating acute ischemic stroke does not increase the risk of kidney problems from the contrast dye. However, there are known risks like radiation exposure and potential adverse effects from the contrast dye used in CTA.
678910How does the extended CTA treatment differ from other treatments for ischemic stroke?
Extended CTA (computed tomography angiography) is unique because it provides a detailed view of blood vessels in the brain, helping to assess the extent of collateral circulation, which is crucial for determining the best treatment approach for acute ischemic stroke. This method is non-invasive and can improve patient management by identifying those who may benefit from reperfusion therapies, potentially leading to better outcomes.
311121314Eligibility Criteria
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
+2 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: extended CTAExperimental Treatment1 Intervention
The standard CTA will be extended 6 cm below the carina
Group II: standard CTAActive Control1 Intervention
Standard CTA performed as standard of care for Stroke Workup
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Health Sciences CentreLondon, Canada
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Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
Lawson Health Research InstituteLead Sponsor
References
Emerging impact of CTA/perfusion CT on acute stroke thrombolysis in a community hospital. [2019]Our objective was to retrospectively review the emerging role of CT, CTA, and perfusion CT (pCT) in the hyperacute stroke population of a community hospital. We reviewed 50 consecutive patients' records and imaging studies, who were treated with thrombolytic therapy within 6 h of symptom onset. Multidetector CT, CTA, and pCT studies were evaluated. Subsequent CT, magnetic resonance, or angiographic studies when available were correlated. Patients' clinical data at admission and outcomes at discharge were evaluated. Complications were tabulated. Of the 50 patients treated with thrombolytics, 37 had CT/CTA/pCT, the others non-contrast CT only. CT blood volume defect was present in a total of 14 patients, presaging permanent infarct in all. Arterial clot was seen in 28/37 CTAs (carotid "T" 6, MCA 16, vertebrobasilar 6). Viable penumbra was shown in 20/37; rescued penumbra was depicted after treatment in 14. 39 patients were treated with intravenous, nine with intra-arterial, two with both forms of thrombolysis. Modified Rankin score showed clinical improvement in 58%, three patients had complete recovery. Subsequent bleed was shown in two (4%), symptomatic in one (2%). Two patients died. Our experience suggests advanced CT is more sensitive to ischemia than routine CT, that salvageable penumbra can be identified, and that triage of patients with acute stroke for thrombolysis with CT/CTA/pCT is more robust than routine CT alone, and may improve outcomes in the community hospital setting.
Clinical application of CT angiography in acute ischemic stroke. [2016]To evaluate the contribution of CT angiography (CTA) in predicting clinical outcome in a broad spectrum of patients presenting with acute neurological deficits suggestive of brain ischemia, to assess its strengths and limitations in this setting, and examine its influence on selection of patients for thrombolytic treatment.
Role of cardiac and extracranial vascular CT in the evaluation/management of cerebral ischemia and stroke. [2021]Collectively, cardiac and large artery sources are responsible for the largest proportion of acute ischemic stroke. Technological advancements in computed tomography (CT) continue to improve evaluation of these patients. The literature was reviewed for the potential role and impact of these innovations in evaluation and management of these patients. In conclusion, incorporation of early cardiac and extracranial vascular CT angiography (CTA) in evaluation of patients with acute ischemic stroke may potentially improve patient management and outcome, while decreasing cost.
Optimal sequence timing of CT angiography and perfusion CT in patients with stroke. [2019]Standard stroke CT protocols start with non-enhanced CT followed by perfusion-CT (PCT) and end with CTA. We aimed to evaluate the influence of the sequence of PCT and CTA on quantitative perfusion parameters, venous contrast enhancement and examination time to save critical time in the therapeutic window in stroke patients.
Patient Outcomes With Use of Computed Tomography Angiography in Acute Ischemic Stroke and Transient Ischemic Attack: A Systematic Review and Meta-Analysis. [2020]Objectives It remains uncertain whether computed tomography angiography (CTA) in ischemic strokes and transient ischemic attacks (TIAs) benefits patient outcomes beyond those eligible for endovascular therapy. We conducted a systematic review and meta-analysis of observational studies and randomized controlled trials (RCTs) investigating the use of CTA against other imaging modalities for recurrent stroke, mortality, disability, emergency department (ED) revisits, or changes in management in ischemic stroke and TIA. (PROSPERO: 349590) Methods MEDLINE, Embase, and CENTRAL were searched. We included studies evaluating CTA against non-CTA imaging modalities for outcomes of interest in ischemic stroke or TIA. Two reviewers extracted data and assessed study quality. Data were pooled by the generic inverse variance method. Heterogeneity was assessed using Cochran's Q statistic and quantified by I2. Quality of the evidence was assessed by GRADE. Results We found 12 eligible cohort studies involving 17,481 patients, and no eligible RCTs. No changes were detected in recurrent stroke, mortality, or disability when CTA was compared against pooled imaging modalities, nor compared to non-contrast computed tomography (NCCT) alone. The evidence for each outcome was graded as low quality to very low quality. Conclusions CTA use was not associated with significant reductions in recurrent stroke, mortality, or disability in ischemic stroke and TIA patient compared with other imaging modalities. More high-quality studies are needed.
Contrast extravasation on CT predicts mortality in primary intracerebral hemorrhage. [2022]Recent studies of intracerebral hemorrhage (ICH) treatments have highlighted the need to identify reliable predictors of hematoma expansion. The goal of this study was to determine whether contrast extravasation on multisection CT angiography (CTA) and/or contrast-enhanced CT (CECT) of the brain is associated with hematoma expansion and increased mortality in patients with primary ICH.
Functional contrast-enhanced CT for evaluation of acute ischemic stroke does not increase the risk of contrast-induced nephropathy. [2021]Concerns have recently grown regarding the safety of iodinated contrast agents used for CTA and CTP imaging. We tested whether the incidence of AN, defined by a >or=25% increase in the post-contrast scan creatinine level, was higher among patients with ischemic stroke who underwent a functional contrast-enhanced CT protocol compared with those who had no iodinated contrast administration.
The role of computed tomography angiogram in intracranial hemorrhage. Do the benefits justify the known risks in everyday practice? [2021]Intracranial hemorrhage is a commonly encountered medical problem frequently evaluated by computed tomography angiography (CTA). In CTA, there is radiation exposure and possible adverse effects of intravenous contrast administration. Therefore, the yield of this diagnostic tool needs to be explored in a heterogeneous group of daily encountered patients to provide insight into the risks and benefits of CTA.
A systematic report on non-coronary cardiac CTA in 1097 patients from the German cardiac CT registry. [2021]To prospectively evaluate contemporary indications, safety and diagnostic impact of cardiac CTA in patients undergoing cardiac CTA examinations for non-coronary clinical indications.
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. [2020]The active extravasation of contrast on CT angiography (CTA) in primary intracerebral hemorrhages (ICH) is recognized as a predictive factor for ICH expansion, unfavorable outcomes and mortality. However, few studies have been conducted on the setting of traumatic brain injury (TBI).
[Neurologic emergencies and multislice computed tomography]. [2021]Modern MSCT with its broad availability and rapid examination times is the preferred modality in the initial evaluation of neurologic emergencies and by its continual development has become more important within recent years. With increased spatial resolution and new post-processing techniques, non-invasive MSCT angiography is seen to increasingly replace diagnostic DSA. Multidetector CTA is a suitable method for the evaluation of intracranial aneurysms, carotid artery stenoses, arterial dissections, as well as cerebral venous and basilar artery thromboses. Multimodal CT (non-enhanced CCT, CTA and perfusion CT) is used more frequently in the assessment of acute stroke patients, it increases the detection rate of early ischemia and is likely to improve the treatment of acute stroke.
Pivotal role of multiphase computed tomography angiography for collateral assessment in patients with acute ischemic stroke. [2023]The cerebral collateral circulation is the main compensatory mechanism that maintains the ischemic penumbra viable, the tissue at risk for infarction that can be saved if blood flow is restored by reperfusion therapies. In clinical practice, the extent of collateral vessels recruited after vessel occlusion can be easily assessed with computed tomography angiography (CTA) using two different techniques: single-phase CTA (sCTA) and multi-phase CTA (mCTA). Both these methodologies have demonstrated a high prognostic predictive value for prognosis due to the strong association between the presence of good collaterals and favorable radiological and clinical outcomes in patients with acute ischemic stroke (AIS). However, mCTA seems to be superior to sCTA in the evaluation of collaterals and a promising tool for identifying AIS patients who can benefit from reperfusion therapies. In particular, it has recently been proposed the use of mCTA eligibility criteria has been recently proposed for the selection of AIS patients suitable for endovascular treatment instead of the current accepted criteria based on CT perfusion. In this review, we analyzed the characteristics, advantages and disadvantages of sCTA and mCTA to better understand their fields of application and the potential of mCTA in becoming the method of choice to assess collateral extent in AIS patients.
Vasospasm after subarachnoid hemorrhage: utility of perfusion CT and CT angiography on diagnosis and management. [2022]To evaluate the utility of perfusion CT (PCT) combined with CT angiography (CTA) for the diagnosis and management of vasospasm, by using conventional digital subtraction angiography (DSA) as the gold standard.
Cardiac CT for intra-cardiac thrombus detection in embolic stroke of undetermined source (ESUS). [2022]Embolic stroke of undetermined source (ESUS) is a common medical challenge regarding secondary prevention strategy. Cardiac imaging is the cornerstone of embolic stroke workup, in an effort to diagnose high risk cardio-embolic sources. Cardiac computed tomography angiography (CCTA) is an emerging imaging modality with high diagnostic performance for intra-cardiac thrombus detection. The yield of CCTA implementation in addition to standard care in ESUS workup is unknown. Thus, the aim of this study was to assess the utility of CCTA in detecting intra-cardiac thrombi in the routine ESUS workup.