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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
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 1, 2018
    Last Updated
    August 1, 2018
    Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow
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    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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