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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01236508
• Other study ID #: 20100606-01H
• Status: Terminated
• Phase: Phase 4
• First received: November 5, 2010
• Last updated: April 21, 2017
• Start date: November 2010
• Est. completion date: October 27, 2016

Study information

• Verified date: April 2017
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives:

1. To investigate the relationship of carotid inflammation, as measured by FDG positron emission tomography (PET) to standardized uptake value in atherosclerotic plaque, with the number of covert brain infarcts.

2. To investigate the relationship of FDG PET standardized uptake value with the relative volume of white matter hyperintensity.

3. To correlate vascular inflammation in the entire aorta and aortoiliac vessels to carotid inflammation and cerebral infarcts and white matter disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 27, 2016
• Est. primary completion date: October 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 12 lead ECG or Holter monitor confirming the absence of atrial fibrillation.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Inflammation
• Leukoencephalopathies
• Stroke
• TIA

Intervention

Radiation:
• PET/CT imaging with F-18 fluorodeoxyglucose
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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital, Civic Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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