Relation of Carotid Artery Plaque Inflammation, Covert St... | NCT01236508

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

NCT01236508

Sponsor

Ottawa Heart Institute Research Corporation

Status

Terminated

Last Update Posted

Apr 24, 2017Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

TIA
Stroke
Carotid Artery Stenosis

Interventions

PET/CT imaging with F-18 fluorodeoxyglucose

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulties recruiting this population for study population

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Oct 27, 2016Actual

Completion Date

Oct 27, 2016Actual

First Submitted Date

Nov 5, 2010

First Submission Date that Met QC Criteria

Nov 5, 2010

First Posted Date

Nov 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2017

Last Update Posted Date

Apr 24, 2017Actual

Name	Class
The Ottawa Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Objectives:

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.
To investigate the relationship of FDG PET standardized uptake value with the relative volume of white matter hyperintensity.
To correlate vascular inflammation in the entire aorta and aortoiliac vessels to carotid inflammation and cerebral infarcts and white matter disease.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nuclear imaging	Experimental	PET/CT imaging with F-18 fluorodeoxyglucose	Radiation: PET/CT imaging with F-18 fluorodeoxyglucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates

ID	Term
D020521	Stroke
D016893	Carotid Stenosis