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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01236508
• Date of registration: 05/11/2010
• Prospective Registration: No
• Primary sponsor: Ottawa Heart Institute Research Corporation
• Public title: Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
• Scientific title: Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
• Date of first enrolment: November 2010
• Target sample size: 50
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01236508
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Terrence Ruddy, MD
• Affiliation: The Ottawa Hospital

Key inclusion & exclusion criteria

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



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Carotid Artery Stenosis

TIA

Intervention(s)

Radiation: PET/CT imaging with F-18 fluorodeoxyglucose

Primary Outcome(s)

Plaque Inflammation [Time Frame: 30 days]

Secondary ID(s)

20100606-01H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Ottawa Hospital