NCT00547976

Brief Summary

Inflammation in the vascular wall is important in atherosclerosis and the blockage of the artery. The peripheral benzodiazepine receptor is involved in inflammation and in this protocol we will attempt to take pictures, using PET camera, of inflammation in patients with atherosclerosis and compare those of healthy people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

October 20, 2007

Last Update Submit

April 26, 2012

Conditions

Keywords

InflammationUnstable PlaqueMacrophageThrombosisAutoradiographyAtherosclerosisVasculitis

Outcome Measures

Primary Outcomes (1)

  • Binding of [11C]PBR28 at peripheral benzodiazepine receptor

    3 years

Secondary Outcomes (1)

  • PET [F-18]FDG uptake

    3 years

Interventions

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 89
  • Ability to provide written informed consent

You may not qualify if:

  • Severe systemic disease based on history, physical examination or laboratory tests that would prevent participation in the study
  • Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual guideline of RSC
  • Pregnancy and breast feeding
  • Claustrophobia
  • Inability to lie flat for a few hours for the PET scans
  • Medically unstable
  • The blood glucose level is greater than 150 mg/dL after fasting
  • Any other condition which in the opinion of the PI would prevent satisfactory participation in and completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • Anholt RR, De Souza EB, Oster-Granite ML, Snyder SH. Peripheral-type benzodiazepine receptors: autoradiographic localization in whole-body sections of neonatal rats. J Pharmacol Exp Ther. 1985 May;233(2):517-26.

    PMID: 2987488BACKGROUND
  • Anholt RR, Murphy KM, Mack GE, Snyder SH. Peripheral-type benzodiazepine receptors in the central nervous system: localization to olfactory nerves. J Neurosci. 1984 Feb;4(2):593-603. doi: 10.1523/JNEUROSCI.04-02-00593.1984.

    PMID: 6321699BACKGROUND
  • Banati RB. Visualising microglial activation in vivo. Glia. 2002 Nov;40(2):206-217. doi: 10.1002/glia.10144.

    PMID: 12379908BACKGROUND
  • Schollhammer R, Lepreux S, Barthe N, Vimont D, Rullier A, Sibon I, Berard X, Zhang A, Kimura Y, Fujita M, Innis RB, Zanotti-Fregonara P, Morgat C. In vitro and pilot in vivo imaging of 18 kDa translocator protein (TSPO) in inflammatory vascular disease. EJNMMI Res. 2021 May 5;11(1):45. doi: 10.1186/s13550-021-00786-7.

MeSH Terms

Conditions

AtherosclerosisInflammationThrombosisVasculitis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 20, 2007

First Posted

October 23, 2007

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations