Clinical trial: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis (NCT01066208)

Eligibility criteria:
Inclusion Criteria for Classification criteria:

          1. Adult patients aged >18 years. There is no upper age limit.

          2. Ability to give informed consent. If the patient is unable to give informed consent as
             a result of death or physical incapacity, then informed assent from next of kin.

          3. Presumed diagnosis of a primary systemic vasculitis.

        Exclusion criteria for classification criteria:

          1. Patients < 18 years of age.

          2. Inability to provide informed consent.

          3. Hepatitis B or C

          4. Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of
             vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.

        Inclusion criteria for diagnostic criteria:

          1. Adult patients aged >18 years. There is no upper age limit.

          2. Ability to give informed consent. If the patient is unable to give informed consent as
             a result of death or physical incapacity, then informed assent from next of kin.

          3. Suspected diagnosis of a primary systemic vasculitis

        Inclusion criteria for controls group for diagnostic criteria:

          1. Adult patients aged >18 years. There is no upper age limit.

          2. Ability to give informed consent. If the patient is unable to give informed consent as
             a result of death or physical incapacity, then informed assent from next of kin.

          3. Patients presenting to secondary care with one of the following clinical
             presentations: I.Multi-system disease. Presentation of disease with at least 2 organs
             involved. II.Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage
             with acute renal impairment. III.Acute renal failure IV.Acute respiratory distress.
             V.Chronic upper airways symptoms and signs. VI.Inflammatory polyarthritis. VII.Fever
             of unknown origin. VIII.Acute or chronic abdominal pain IX.Hypertension. X.Referred to
             secondary care with suspicion of vasculitis but confirmed not to have vasculitis.
             XII.New onset headache. XIII.Jaw or tongue pain. XIV.Sudden visual loss. XV.Limb
             claudication. XVI.Aortic aneurysm >5cm.

        Exclusion Criteria for diagnostic criteria:

          1. Patients under the age of 18

          2. Patient or next of kin unable or unwilling to provide informed consent or assent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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? Entailment