Prospective Evaluation of Carotid Free-floating Thrombus
Primary Purpose
Stroke, Transient Ischemic Attack
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computed Tomographic Angiogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring Atherosclerosis, Internal Carotid Artery, Free-floating thrombus, Ulcerated plaque, FFT
Eligibility Criteria
Inclusion Criteria:
- TIA/Stroke within 72 hours
- CTA showing a symptom-relevant ICA lesion (stenosis >50%)
- informed consent
Exclusion Criteria:
- creatinine clearance <60 mg/ml
- allergy to contrast media
Sites / Locations
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CT Angiogram
Arm Description
A research CTA scan may be required if there is no change of the imaging on the 3 CTA scans prior.
Outcomes
Primary Outcome Measures
Length of intraluminal filling defect on CTA as a measure to distinguish FFT from stable ulcerated plaque
Secondary Outcome Measures
Prevalence of FFT among patients with ambiguous diagnosis measured by follow-up CTA scans
Clinician treatment strategies used to manage FFT
Future antithrombotic treatment trial measured by data collection tools and pilot data
Full Information
NCT ID
NCT02405845
First Posted
March 11, 2015
Last Updated
October 7, 2021
Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02405845
Brief Title
Prospective Evaluation of Carotid Free-floating Thrombus
Official Title
Prospective Evaluation of Intraluminal Internal Carotid Artery Free-Floating Thrombus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
September 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hardened plaque located in the carotid arteries can cause stroke or transient ischemic attack (TIA). This type of plaque is linked to unstable free-floating thrombi (FFT). FFT are blood clots that form in a blood vessel, and are at the highest risk for travelling within the bloodstream and causing strokes. Physicians are able to see this type of plaque with computed tomographic angiography (CTA) but FFT look very similar to stable types of plaque that do not require urgent treatment.
Distinguishing between these plaques is important because it affects the choice and urgency of treatment that patients receive.
The researchers have found a promising visual marker on CTA scans. The goal of this study is to determine if this visual marker seen on CTA scans will help to distinguish FFT plaque from stable plaque.
Detailed Description
Atherosclerotic plaques at the origin of the internal carotid artery (ICA) can cause TIA/stroke, and are well-visualized with CT angiography (CTA). Those plaques associated with unstable free-floating thrombi (FFT) are at highest risk for embolization and stroke. Unfortunately, FFT have a similar appearance to stable ulcerated plaques on CTA: both appear as intraluminal filling defects of varying length and morphology. Distinguishing these entities is critical as it affects the choice and urgency of treatment (antithrombotics vs revascularization). Using a retrospective study, we have previously proposed a promising CTA imaging marker to distinguish FFT from stable ulcerated plaque. It is hoped that after the data is collected from this prospective study to one day initiate a multi-centre study.
In our prior research, we proposed a reasonable "gold standard" for FFT diagnosis. We followed patients presenting with circular filling defects on CTA (doughnut signs) suspicious for either FFT or ulcerated plaque with serial CTAs after medical therapy. Those that diminished or resolved with antithrombotic treatment (or those that unfortunately "resolved" by embolizing distally) were presumed to be "true FFT" in contrast to those that remained unchanged. We then assessed the performance of a variety of imaging parameters to differentiate FFT from ulcerated plaque: we tested linear measurements, morphology, degree of stenosis, as well as relevant clinical factors. These parameters were measured by neuroradiologists as well as an innovative semi-automated shape analysis. Using a retrospectively established cohort, we were able to derive 3.8 mm as an optimal cranial-caudal length threshold of the filling defect that can potentially help distinguish FFT from plaque, with 88% sensitivity and 86% specificity.
We will prospectively identify consecutive patients presenting with TIA/stroke within 72 hrs of symptom onset with an ICA intraluminal filling defect on CTA. We will review the imaging data and measure the cranial-caudal length of the filling defect. Patients will receive a follow-up CTA in one week as per the current clinical standard of care, and if the defect is still unresolved, a third CTA will be repeated after a second week if unresolved, and a fourth at one month (research). We will measure cranial-caudal length of the filling defect at each time interval, blind to the previous measurements. Resolution of the filling defect at any point is diagnostic of FFT, whereas its static appearance after 1 month is diagnostic of ulcerated plaque. For this pilot study, measure rate of enrolment, adherence to study protocols, attrition rates, and proportion of patients with FFT. For the exploratory objective, we will record treatment choice, dose, and duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
Atherosclerosis, Internal Carotid Artery, Free-floating thrombus, Ulcerated plaque, FFT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT Angiogram
Arm Type
Other
Arm Description
A research CTA scan may be required if there is no change of the imaging on the 3 CTA scans prior.
Intervention Type
Radiation
Intervention Name(s)
Computed Tomographic Angiogram
Other Intervention Name(s)
CTA, CT Angiogram
Intervention Description
1 additional non-clinical CTA per patient enrolled in the study. The estimated radiation risk from a single CTA of the neck and brain is approximately 3.6 millisieverts (mSv), an exposure similar to a single airplane flight across Canada.
Primary Outcome Measure Information:
Title
Length of intraluminal filling defect on CTA as a measure to distinguish FFT from stable ulcerated plaque
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Prevalence of FFT among patients with ambiguous diagnosis measured by follow-up CTA scans
Time Frame
12 months
Title
Clinician treatment strategies used to manage FFT
Time Frame
18 months
Title
Future antithrombotic treatment trial measured by data collection tools and pilot data
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
TIA/Stroke within 72 hours
CTA showing a symptom-relevant ICA lesion (stenosis >50%)
informed consent
Exclusion Criteria:
creatinine clearance <60 mg/ml
allergy to contrast media
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Torres, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34426550
Citation
Torres C, Lum C, Puac-Polanco P, Stotts G, Shamy MCF, Blacquiere D, Lun R, Dave P, Bharatha A, Menon BK, Thornhill R, Momoli F, Dowlatshahi D. Differentiating Carotid Free-Floating Thrombus From Atheromatous Plaque Using Intraluminal Filling Defect Length on CTA: A Validation Study. Neurology. 2021 Aug 24;97(8):e785-e793. doi: 10.1212/WNL.0000000000012368. Epub 2021 Jun 14.
Results Reference
derived
Learn more about this trial
Prospective Evaluation of Carotid Free-floating Thrombus
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