Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease

NCT01236508 | Terminated Phase 4

• 1 other identifier: 20100606-01H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that inflammation in carotid plaque is predictive of the extent of ischemic lesion burden on the brain and will add to risk stratification for individuals with carotid disease.

Conditions

TIA; Stroke; Carotid Artery Stenosis

Keywords

White Matter Hyperintensity; Stroke; Carotid Artery Plaque Inflammation; FDG PET; MRI; TIA

Outcome Measures

Primary Outcomes (1)

• Plaque Inflammation

  The extent to which plaque inflammation, as measured by the extent of FDG uptake, contributes to the number of covert infarcts and the magnitude of white matter hyperintensity.

  30 days

Study Arms (1)

Nuclear imaging

EXPERIMENTAL

PET/CT imaging with F-18 fluorodeoxyglucose

Radiation: PET/CT imaging with F-18 fluorodeoxyglucose

Interventions

PET/CT imaging with F-18 fluorodeoxyglucose RADIATION

Dose of 5 MBq/kg F-18-FDG given to fasting participant. Nuclear whole body imaging starting at 3 hours post-injection. The relation of the PET/CT image results and both the number of covert brain infarcts and the extent of white matter MRI hyperintensity will be investigated.

Nuclear imaging

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 or greater at time of enrollment
• Written informed consent from patient or legal representative
• Diagnosis of stroke or TIA made by a stroke specialist within 90 days and fulfilling the following criteria:
• A TIA must involve a focal speech/language, motor or visual deficit (transient monocular blindness, amaurosis fugax) referable to the distribution of a carotid artery and lasting less than 24 hours.
• A stroke consisting of deficits as noted above with duration greater than 24 hours and/or confirmed on cerebral imaging. Post event Modified Rankin Score of 2 or less.
• Stroke meets the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria for large artery atherosclerosis
• Carotid Doppler, CTA or MRA confirming the presence of bilateral atherosclerotic disease resulting in carotid stenosis of any degree. Stenosis will be measured following the method used in NASCET for CTA and MRA. Carotid Doppler measurements will follow the criteria defined by the Society for Ultrasound consensus conference.
• lead ECG or Holter monitor confirming the absence of atrial fibrillation.

You may not qualify if:

• TIA or stroke in the vertebrobasilar system
• Index event was primary hemorrhage
• History of intermittent atrial fibrillation
• Cardiac source of embolus suspected as cause of index event (artificial valve, segmental or global LV dysfunction, congenital cardiac defect)
• Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans)
• Sinovenous thrombosis, endocarditis or hypercoagulable state
• Pacemaker, ICD or other contraindications to MRI
• Diminished Kidney Function
• Contraindication to radiation exposure (eg: pregnancy)
• Severe Claustrophobia

Sponsors & Collaborators

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

Study Sites (1)

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Stroke; Carotid Stenosis

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Terrence Ruddy, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: October 27, 2016
• Study Completion: October 27, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

CA (1)