Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA

Study Overview
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Brief Summary
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Stroke affects over 125,000 people each year in the UK and leaves at least 50% disabled. After a first stroke, there is a significant risk of recurrence (around 5-10% over the first year). While there are benefits from addressing general risk factors such as exercise, weight and smoking, selecting the best treatments for preventing a further stroke depends on understanding the underlying mechanism. Most strokes results from a blood clot causing a blockage in a blood vessel in the brain (ischaemic strokes, about 85% of cases). The clot may originate in the heart, the major blood vessels supplying the head, or result from disease of the small blood vessels in the brain itself (around 25% of cases each), and in around 25% of people a cause cannot be determined (sometimes because more than one exists). Different treatments are given depending on cause (for example, anticoagulant medication for clots from the heart, surgery for some arising from large arteries in the neck). Current investigations involve multiple tests spread across different hospital departments, and commonly take several weeks to be completed. This may contribute to a high rate of strokes of uncertain cause, and may delay the start of the best treatment. This trial will investigate the value of a single comprehensive scan to look at the heart and major blood vessels (using CT scanning) in a pilot study, comparing the classification of causes of stroke and the time to starting treatments with routine care, in a randomised study of patients with recent stroke or transient ischaemic attack (TIA, a short-lived stroke episode).

Official Title
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Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and Transient Ischaemic Attacks

Conditions
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Transient Ischaemic Attack, Stroke

Intervention / Treatment
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* Diagnostic Test: CCI scanning (CTA, cardiac CT), and MRI scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ischaemic stroke or TIA Male or non-pregnant female≥18 years of age. Informed consent. Exclusion Criteria: Known impaired renal function precluding contrast Computed Tomography (CT). Contraindications to MRI scans Known severe hypersensitivity to iodine based contrast media for CT or gadolinium based contrast agents for MRI. Severe concurrent medical condition that would prevent participation in study procedures (e.g. severe pulmonary oedema or severe septicemia) or with life expectancy ≤ 1 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: routine investigation<br> | |
| Active Comparator: study protocol CCI (CTA, cardiac CT) and MRI scans<br> | Diagnostic Test: CCI scanning (CTA, cardiac CT), and MRI scanning<br>* Scanning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patient with stroke of uncertain aetiology by ASCO system classification by day 30. Uncertain aetiology may include cases where insufficient investigation prevents aetiological classification. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach final aetiological classification |  | 30 days | 
| Medication usage |  | 30 days | 
| Diagnostic investigation usage |  | 30 days | 
| Incidence of new stroke or TIA |  | 30 days |