Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy
CAROTEP
Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study
1 other identifier
interventional
20
1 country
1
Brief Summary
This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 27, 2017
CompletedStudy Start
First participant enrolled
September 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 13, 2020
January 1, 2020
1.7 years
April 14, 2017
January 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
carotid F18-NaF uptake
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination
baseline
Secondary Outcomes (3)
comparaison of F18-NaF PET and Carotid MRI
baseline
F18-NaF PET uptake
baseline
histology
baseline
Study Arms (2)
symptomatic
ACTIVE COMPARATORasymptomatic
ACTIVE COMPARATORInterventions
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging
Eligibility Criteria
You may qualify if:
- Age over 18 years old
- Health care system affiliation
- Referred to carotid endarterectomy
- Symptomatic patients:
- Carotid stenosis between 70 and 99% (NASCET criteria)
- TIA or minor stroke attack (RANKIN ≤ 3)
- Asymptomatic patients:
- Carotid stenosis between 70 and 99% (NASCET criteria)
- No symptoms
- Patient who has been informed of the study and has given his/her informed consent
You may not qualify if:
- Contra indication to MRI
- Renal failure (clearance \< 30ml/mn)
- Patient with active inflammatory disease
- History of cancer
- Pregnancy or lactation
- Patient with carotid disease treated by fibrinolysis
- Patient under guardianship, or unable to understand the purpose of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen University Hospital
Caen, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
November 27, 2017
Study Start
September 3, 2018
Primary Completion
June 1, 2020
Study Completion
June 1, 2021
Last Updated
January 13, 2020
Record last verified: 2020-01