Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA

NCT03618069 | Unknown

• 1 other identifier: GN17ST585
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Stroke; Transient Ischaemic Attack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

routine investigation

NO INTERVENTION

study protocol CCI (CTA, cardiac CT) and MRI scans

ACTIVE COMPARATOR

Diagnostic Test: CCI scanning (CTA, cardiac CT), and MRI scanning

Interventions

CCI scanning (CTA, cardiac CT), and MRI scanning DIAGNOSTIC_TEST

Scanning

study protocol CCI (CTA, cardiac CT) and MRI scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of ischaemic stroke or TIA
• Male or non-pregnant female≥18 years of age.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Central Study Contacts

Anis Guweidhi

CONTACT

0141 451 5903; a.guweidhi.1@research.gla.ac.uk

Alicia Murray

CONTACT

0141 451 5903; Alicia.Murray@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 7, 2018
• Study Start: September 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08