Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy (CAROTEP)

C

Caen University Hospital

Status and phase

Unknown
Phase 2

Conditions

Carotid Artery Stenosis

Treatments

Drug: Sodium fluoride F-18 PET imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT03353103
17-012

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

symptomatic
Active Comparator group
Treatment:
Drug: Sodium fluoride F-18 PET imaging
asymptomatic
Active Comparator group
Treatment:
Drug: Sodium fluoride F-18 PET imaging

Trial contacts and locations

0

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Central trial contact

Lucie Cameliere, MD; Alain Manrique, MD PhD

Data sourced from clinicaltrials.gov

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