NCT02523625

Brief Summary

Giant cell arteritis (GCA) is an inflammatory disease causing new, unaccustomed headache in the elderly and which can lead to blindness in 20-30% of untreated cases. The study group have previously shown that ultrasound is a viable non-invasive alternative to temporal artery biopsy in diagnosing GCA. However, there is significant variation in ultrasound assessment (measuring a dark "halo" around the abnormal blood vessels) between sonographers in different centres, requiring a labour intensive and time consuming training programme. The study group propose to standardise the training programme, and use ultrasound and clinical evaluation to define changes occurring over time and with treatment in patients with a diagnosis of GCA made based on ultrasound changes alone. The study group will explore the use of algorithms to automate or semi-automate image interpretation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

August 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

1.9 years

First QC Date

August 4, 2015

Last Update Submit

August 12, 2015

Conditions

Giant Cell Arteritis

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Size of halo detected (mm) on ultrasound of temporal arteries

    The study group will compare computer algorithms to analyse the halo size from video images of ultrasound scans with observer defined measures of halo size (mm) from healthy volunteers, patients with headache but not due to GCA, patients with newly diagnosed GCA and in patients with GCA who are followed serially and re-imaged over time in response to therapy. The study group will test the value of algorithms incorporating clinical and serological data together with the imaging findings to determine their added effect on the sensitivity and specificity of ultrasound for diagnosis and monitoring of GCA. Halo size varies from 0 (undetectable) to greater than 1mm. Cut-off values for abnormal values have not been formally established or published yet.

    24 months

Secondary Outcomes (2)

  • Circulating serum Vascular Endothelial Growth Factor (VEGF) levels

    24 months

  • Circulating serum Pentraxin 3 levels

    24 months

Study Arms (4)

Healthy volunteers

Age and gender matched to patient groups to undergo ultrasound of temporal and axillary arteries

Device: Ultrasound of temporal and axillary arteries

Patients with headache

Patients with new headache not due to GCA to undergo ultrasound of temporal and axillary arteries

Device: Ultrasound of temporal and axillary arteries

Patients with GCA (new)

Patients with new diagnosis of GCA to undergo ultrasound of temporal and axillary arteries

Device: Ultrasound of temporal and axillary arteries

Patients with GCA (flare)

Patients with apparent flare of GCA to undergo ultrasound of temporal and axillary arteries

Device: Ultrasound of temporal and axillary arteries

Interventions

Ultrasound of temporal and axillary arteriesDEVICE

Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries

Healthy volunteersPatients with GCA (flare)Patients with GCA (new)Patients with headache

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or diagnosed giant cell arteritis

You may qualify if:

  • Healthy volunteer or
  • Patient with a suspected diagnosis of GCA but found not to have GCA
  • Recent diagnosis of GCA within 1 month or
  • Suspected flare of GCA within one month
  • Ability to provide written informed consent

You may not qualify if:

  • Unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Ponte C, Rodrigues AF, O'Neill L, Luqmani RA. Giant cell arteritis: Current treatment and management. World J Clin Cases. 2015 Jun 16;3(6):484-94. doi: 10.12998/wjcc.v3.i6.484.

    PMID: 26090367RESULT

  • Diamantopoulos AP, Myklebust G. Long-term inflammation in the temporal artery of a giant cell arteritis patient as detected by ultrasound. Ther Adv Musculoskelet Dis. 2014 Jun;6(3):102-3. doi: 10.1177/1759720X14521109. No abstract available.

    PMID: 24891881RESULT

  • Schmidt WA. Ultrasound in vasculitis. Clin Exp Rheumatol. 2014 Jan-Feb;32(1 Suppl 80):S71-7. Epub 2014 Feb 17.

    PMID: 24529335RESULT

  • Diamantopoulos AP, Haugeberg G, Hetland H, Soldal DM, Bie R, Myklebust G. Diagnostic value of color Doppler ultrasonography of temporal arteries and large vessels in giant cell arteritis: a consecutive case series. Arthritis Care Res (Hoboken). 2014 Jan;66(1):113-9. doi: 10.1002/acr.22178.

    PMID: 24106211RESULT

  • Muratore F, Boiardi L, Restuccia G, Macchioni P, Pazzola G, Nicolini A, Germano G, Possemato N, Cavazza A, Cavuto S, Cimino L, Pipitone N, Catanoso M, Addimanda O, Salvarani C. Comparison between colour duplex sonography findings and different histological patterns of temporal artery. Rheumatology (Oxford). 2013 Dec;52(12):2268-74. doi: 10.1093/rheumatology/ket258. Epub 2013 Sep 17.

    PMID: 24046471RESULT

  • Habib HM, Essa AA, Hassan AA. Color duplex ultrasonography of temporal arteries: role in diagnosis and follow-up of suspected cases of temporal arteritis. Clin Rheumatol. 2012 Feb;31(2):231-7. doi: 10.1007/s10067-011-1808-0. Epub 2011 Jul 9.

    PMID: 21743987RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Whole blood

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Raashid A Luqmani, DM FRCP

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raashid A Luqmani, DM FRCP

CONTACT

01865227971raashid.luqmani@ndorms.ox.ac.uk

Jana Vaskova

CONTACT

01865227971jana.vaskova@ndorms.ox.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 14, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2017

Study Completion

June 1, 2018

Last Updated

August 14, 2015

Record last verified: 2015-08