Giant Cell Arteritis
Conditions
Brief summary
Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is based on a combination of clinical, biological and histological signs. Temporal artery biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since the description by Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as second line method, many authors suggest the possibility to do without TAB in many cases. In addition, many practitioners believe that it is not ethical to use an invasive unprofitable procedure like TAB, and have already been using CDU in their routine practice. However, no diagnostic algorithm validating this approach in a prospective series has been published to date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first screening method.
Interventions
OTHERcolor Doppler ultrasound and TAB in case of CDU negative
Screening with color Doppler ultrasound followed by TAB in case of CDU negative
Sponsors
Groupe Hospitalier de la Rochelle Ré Aunis
Centre Hospitalier de Rochefort
Poitiers University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 50 years * C reactive protein (CRP) above normal * Suspected of GCA according to clinician expertise and / or aortitis arteritis or of one or more arteries from the aorta imaging (CT angiography, magnetic resonance angiography or positron emission tomography TDM18FDG) * Benefiting from Social Security or receiving it via a third party * have given their participation agreement by understanding and accepting the constraints of the study
Exclusion criteria
* Received corticosteroid dose ≥ 20 mg of prednisone equivalent for more than 7 days in the month before inclusion * Underwent temporal artery biopsy before color Doppler ultrasound * History of GCA * Terminal palliative phase or suffering from a disease or comorbidities such as life is involved in less than a year * Patient with severe cognitive impairment * Patient that can not be followed by the investigator for the duration of the study * Refusal to participate in the study * With enhanced protection (namely those deprived of liberty by a court or administrative order, patient staying in a health or social institution, under legal protection, and patients in emergencies) * Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception * Participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of CDU False-positive Patients | after 2 years of follow-up | patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler positive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Temporal Artery Biopsy Positive Among Negative or Doubtful CDU | within 1 month (during diagnostic algorithm) | Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU |
| Number of Patients With a Persistent Halo at Second CDU Examination | after 2 years of follow-up | Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response |
| Number of Correctly Interpreted TAB | 1 month (after second blind reading of histological specimen and doppler imaging) | Reproducibility of TAB interpretation |
| Number of Correctly Interpreted CDU | 1 month (after second blind reading of histological specimen and doppler imaging) | Reproducibility of CDU interpretation |
Countries
France
Participant flow
Recruitment details
Recruitment period: from end of August 2016 to February 2020 Type of location: five public hospitals
Participants by arm
| Arm | Count |
|---|---|
| CDU Positive A first screening is performed using color Doppler ultrasound (CDU).
CDU Positive refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound | 73 |
| CDU Negative A first screening is performed using color Doppler ultrasound (CDU).
CDU negative refers to patient with no sign or a unilateral halo sign on the temporal artery. | 92 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 8 |
| Overall Study | Lost to Follow-up | 10 | 10 |
Baseline characteristics
| Characteristic | CDU Negative | Total | CDU Positive |
|---|---|---|---|
| Age, Continuous | 78 years STANDARD_DEVIATION 9.6 | 78.7 years STANDARD_DEVIATION 8.8 | 79.6 years STANDARD_DEVIATION 7.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 92 participants | 165 participants | 73 participants |
| Sex: Female, Male Female | 60 Participants | 102 Participants | 42 Participants |
| Sex: Female, Male Male | 32 Participants | 63 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 73 | 8 / 92 |
| other Total, other adverse events | 51 / 73 | 50 / 92 |
| serious Total, serious adverse events | 12 / 73 | 18 / 92 |
Outcome results
Primary
Number of CDU False-positive Patients
patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler positive.
Time frame: after 2 years of follow-up
Population: Patients followed up at two years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDU Positive | Number of CDU False-positive Patients | Patients diagnosed with giant cell arteritis | 73 Participants |
| CDU Positive | Number of CDU False-positive Patients | Alternative diagnosis | 0 Participants |
| CDU Negative | Number of CDU False-positive Patients | Patients diagnosed with giant cell arteritis | 63 Participants |
| CDU Negative | Number of CDU False-positive Patients | Alternative diagnosis | 29 Participants |
Secondary
Number of Correctly Interpreted CDU
Reproducibility of CDU interpretation
Time frame: 1 month (after second blind reading of histological specimen and doppler imaging)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CDU Positive | Number of Correctly Interpreted CDU | First analysis | Positive | 73 Participants |
| CDU Positive | Number of Correctly Interpreted CDU | First analysis | negative | 0 Participants |
| CDU Positive | Number of Correctly Interpreted CDU | First analysis | Not available | 0 Participants |
| CDU Positive | Number of Correctly Interpreted CDU | Blinded expert analysis | Positive | 42 Participants |
| CDU Positive | Number of Correctly Interpreted CDU | Blinded expert analysis | negative | 16 Participants |
| CDU Positive | Number of Correctly Interpreted CDU | Blinded expert analysis | Not available | 15 Participants |
| CDU Negative | Number of Correctly Interpreted CDU | Blinded expert analysis | negative | 75 Participants |
| CDU Negative | Number of Correctly Interpreted CDU | First analysis | Positive | 0 Participants |
| CDU Negative | Number of Correctly Interpreted CDU | Blinded expert analysis | Positive | 3 Participants |
| CDU Negative | Number of Correctly Interpreted CDU | First analysis | negative | 92 Participants |
| CDU Negative | Number of Correctly Interpreted CDU | Blinded expert analysis | Not available | 14 Participants |
| CDU Negative | Number of Correctly Interpreted CDU | First analysis | Not available | 0 Participants |
Secondary
Number of Correctly Interpreted TAB
Reproducibility of TAB interpretation
Time frame: 1 month (after second blind reading of histological specimen and doppler imaging)
Population: According to the diagnostic algorithm, only ultrasound-negative patients underwent temporal artery biopsy within 7 days after the ultrasound
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CDU Positive | Number of Correctly Interpreted TAB | First analysis | Negative | 58 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | First analysis | Positive | 28 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | First analysis | inconclusive | 6 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | First analysis | Not available | 0 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | Blinded expert analysis | Negative | 55 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | Blinded expert analysis | Positive | 18 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | Blinded expert analysis | inconclusive | 4 Participants |
| CDU Positive | Number of Correctly Interpreted TAB | Blinded expert analysis | Not available | 15 Participants |
Secondary
Number of Patients With a Persistent Halo at Second CDU Examination
Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response
Time frame: after 2 years of follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDU Positive | Number of Patients With a Persistent Halo at Second CDU Examination | Stable | 9 Participants |
| CDU Positive | Number of Patients With a Persistent Halo at Second CDU Examination | Improvement | 30 Participants |
| CDU Positive | Number of Patients With a Persistent Halo at Second CDU Examination | No more Halo | 25 Participants |
| CDU Positive | Number of Patients With a Persistent Halo at Second CDU Examination | Not done | 9 Participants |
Secondary
Rate of Temporal Artery Biopsy Positive Among Negative or Doubtful CDU
Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU
Time frame: within 1 month (during diagnostic algorithm)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDU Positive | Rate of Temporal Artery Biopsy Positive Among Negative or Doubtful CDU | TAB negative | 28 Participants |
| CDU Positive | Rate of Temporal Artery Biopsy Positive Among Negative or Doubtful CDU | TAB positive | 57 Participants |
| CDU Positive | Rate of Temporal Artery Biopsy Positive Among Negative or Doubtful CDU | Uninterpretable | 7 Participants |