Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA (DCCIST)

Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and Transient Ischaemic Attacks

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).

Study Overview

• Status: Unknown
• Conditions: Stroke; Transient Ischaemic Attack
• Intervention / Treatment: Diagnostic test: CCI scanning (CTA, cardiac CT), and MRI scanning

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anis Guweidhi; Phone Number: 0141 451 5903; Email: a.guweidhi.1@research.gla.ac.uk
• Study Contact Backup: Name: Alicia Murray; Phone Number: 0141 451 5903; Email: Alicia.Murray@glasgow.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: routine investigation
ACTIVE_COMPARATOR: study protocol CCI (CTA, cardiac CT) and MRI scans	Diagnostic test: CCI scanning (CTA, cardiac CT), and MRI scanning; Scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): August 30, 2019
• Study Completion (ANTICIPATED): August 30, 2019

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (ACTUAL): August 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Attack, Transient
• Other Study ID Numbers: GN17ST585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No