Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA (DCCIST)
Primary Purpose
Stroke, Transient Ischaemic Attack
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CCI scanning (CTA, cardiac CT), and MRI scanning
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
routine investigation
study protocol CCI (CTA, cardiac CT) and MRI scans
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to reach final aetiological classification
Medication usage
Diagnostic investigation usage
Incidence of new stroke or TIA
Full Information
NCT ID
NCT03618069
First Posted
August 1, 2018
Last Updated
August 1, 2018
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
1. Study Identification
Unique Protocol Identification Number
NCT03618069
Brief Title
Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA
Acronym
DCCIST
Official Title
Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and Transient Ischaemic Attacks
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischaemic Attack
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
routine investigation
Arm Type
No Intervention
Arm Title
study protocol CCI (CTA, cardiac CT) and MRI scans
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
CCI scanning (CTA, cardiac CT), and MRI scanning
Intervention Description
Scanning
Primary Outcome Measure Information:
Title
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to reach final aetiological classification
Time Frame
30 days
Title
Medication usage
Time Frame
30 days
Title
Diagnostic investigation usage
Time Frame
30 days
Title
Incidence of new stroke or TIA
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anis Guweidhi
Phone
0141 451 5903
Email
a.guweidhi.1@research.gla.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Murray
Phone
0141 451 5903
Email
Alicia.Murray@glasgow.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA
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