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Extended CTA for Ischemic Stroke Detection (DAYLIGHT Trial)
N/A
Recruiting
Led By Luciano Sposato, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will help us better understand the role of LAA thrombi in ESUS and identify risk factors for stroke recurrence. #ESUS #CryptogenicStroke #TEE #CTA #LAAThrombi
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects mainly relate to CTA and may include reactions to contrast dye like rash or itching, kidney function impairment especially in those already at risk, and discomfort from lying still during scanning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy Outcome: The proportion of participants with a confirmed or "highly suspected" newly diagnosed cardioaortic thrombus
Secondary study objectives
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.
Secondary efficacy outcome 2: The proportion of participants diagnosed with a cardio-aortic embolic source known to increase the risk of stroke.
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.
Other study objectives
Primary Safety Outcome 1: door to sCTA time vs door to eCTA
Secondary Safety Outcome 1: Door-to-needle
Secondary Safety Outcome 2: Door-to-groin puncture
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,103 Total Patients Enrolled
16 Trials studying Stroke
8,931 Patients Enrolled for Stroke
Luciano Sposato, MDPrincipal InvestigatorLondon Health Sciences Center, Western University
2 Previous Clinical Trials
56 Total Patients Enrolled
2 Trials studying Stroke
56 Patients Enrolled for Stroke
Rodrigo Bagur, MDPrincipal InvestigatorLondon Health Sciences Center, Western University
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