TIAPhase 4NCT01236508
Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
A Phase 4 study testing PET/CT imaging with F-18 fluorodeoxyglucose in people with TIA and Stroke, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- TIA, Stroke, Carotid Artery Stenosis
- What is being tested?
- PET/CT imaging with F-18 fluorodeoxyglucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to 27 Oct 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Pacemaker, ICD or other contraindications to MRI
- Diminished Kidney Function
- Contraindication to radiation exposure (eg: pregnancy)
- Severe Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- TIA, Stroke, Carotid Artery Stenosis
- Being tested
- PET/CT imaging with F-18 fluorodeoxyglucose
- Keywords
- White Matter Hyperintensity, Stroke, Carotid Artery Plaque Inflammation, FDG PET, MRI, TIA
- Medical subject headings
- Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT imaging with F-18 fluorodeoxyglucoseRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Nuclear imaging | Experimental | PET/CT imaging with F-18 fluorodeoxyglucose Receives: Radiation: PET/CT imaging with F-18 fluorodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completion27 Oct 2016
- Study completion27 Oct 2016
Why it stopped: difficulties recruiting this population for study population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TIAStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence Ruddy, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236508
- Sponsor's protocol ID
- 20100606-01H
- Status last verified
- Apr 2017
- First submitted
- 5 Nov 2010
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
- ClinicalTrials.gov ID
- NCT01236508
- Acronym / sponsor ID
- 20100606-01H
- Conditions
- TIA, Stroke, Carotid Artery Stenosis
- Keywords
- White Matter Hyperintensity, Stroke, Carotid Artery Plaque Inflammation, FDG PET, MRI, TIA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties recruiting this population for study population
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Nov 2010
- Primary completion
- 27 Oct 2016 (actual)
- Study completion
- 27 Oct 2016 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nuclear imaging | Experimental | Radiation: PET/CT imaging with F-18 fluorodeoxyglucosePET/CT imaging with F-18 fluorodeoxyglucose |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT imaging with F-18 fluorodeoxyglucoseDose 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. | Radiation | Nuclear imaging |
Primary outcome
Plaque Inflammation
Time frame: 30 days
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.
Results and safety
The study was stopped early (reason given: difficulties recruiting this population for study population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence Ruddy, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PET/CT imaging with F-18 fluorodeoxyglucose in people with TIA and Stroke, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulties recruiting this population for study population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Inflammation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.