Clinical trial: Validation of a Diagnostic Algorithm of Giant Cell Arteritis (NCT02703922)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing.  He also complains of fatigue and hip muscle aches over the last several months.  The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications.  On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min.  Neurological examination is unremarkable.  Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation.

Patient description (patient's own words): I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage.

Does the patient match the trial criteria? 0