Prospective Evaluation of Carotid Free-floating Thrombus

NCT02405845 | Completed

• 1 other identifier: OHSN-REB 20150092-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Transient Ischemic Attack

Keywords

Atherosclerosis; Internal Carotid Artery; Free-floating thrombus; Ulcerated plaque; FFT

Outcome Measures

Primary Outcomes (1)

• Length of intraluminal filling defect on CTA as a measure to distinguish FFT from stable ulcerated plaque

  12 months

Secondary Outcomes (3)

• Prevalence of FFT among patients with ambiguous diagnosis measured by follow-up CTA scans

  12 months

• Clinician treatment strategies used to manage FFT

  18 months

• Future antithrombotic treatment trial measured by data collection tools and pilot data

  18 months

Study Arms (1)

CT Angiogram

OTHER

A research CTA scan may be required if there is no change of the imaging on the 3 CTA scans prior.

Radiation: Computed Tomographic Angiogram

Interventions

Computed Tomographic Angiogram RADIATION

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.

Also known as: CTA, CT Angiogram

CT Angiogram

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• TIA/Stroke within 72 hours
• CTA showing a symptom-relevant ICA lesion (stenosis \>50%)
• informed consent

You may not qualify if:

• creatinine clearance \<60 mg/ml
• allergy to contrast media

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• 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.

  PMID: 34426550 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Carlos Torres, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: April 1, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

CA (1)