DCCIST: Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and TIA

Sponsor
NHS Greater Glasgow and Clyde (Other)
Overall Status
Unknown status
CT.gov ID
NCT03618069
Collaborator
University of Glasgow (Other)
100
2
11.9

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CCI scanning (CTA, cardiac CT), and MRI scanning
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnosis by Comprehensive Cardiovascular Imaging for Stroke and Transient Ischaemic Attacks
Anticipated Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Aug 30, 2019
Anticipated Study Completion Date :
Aug 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Time to reach final aetiological classification [30 days]

  2. Medication usage [30 days]

  3. Diagnostic investigation usage [30 days]

  4. Incidence of new stroke or TIA [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • NHS Greater Glasgow and Clyde
  • University of Glasgow

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT03618069
Other Study ID Numbers:
  • GN17ST585
First Posted:
Aug 7, 2018
Last Update Posted:
Aug 7, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2018