Giant Cell Arteritis and PET Scan (GAPS) Study
Maneno muhimu
Kikemikali
Tarehe
| Imethibitishwa Mwisho: | 02/29/2020 |
| Iliyowasilishwa Kwanza: | 05/08/2016 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 05/10/2016 |
| Iliyotumwa Kwanza: | 05/12/2016 |
| Sasisho la Mwisho Liliwasilishwa: | 03/09/2020 |
| Sasisho la Mwisho Lilichapishwa: | 03/11/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 05/14/2016 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 01/27/2020 |
| Tarehe ya Kukamilisha Utafiti: | 01/27/2020 |
Hali au ugonjwa
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Suspected GCA (GCA final diagnosis) | |
| Suspected GCA (alternative final diagnosis) |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 50 Years Kwa 50 Years |
| Jinsia Inastahiki Kujifunza | All |
| Njia ya sampuli | Probability Sample |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Rheumatologist, neurologist or ophthalmologist suspect diagnosis of GCA - Age > 50 - Meet at least 2 of 1990 American College of Rheumatology classification criteria for GCA 1. Age >= 50 2. ESR >= 50 3. New onset localised headache 4. Temporal artery abnormality (tenderness or decreased pulsation) 5. Positive biopsy (will not be available at time of enrolment) Exclusion Criteria: - Corticosteroid therapy for > 72 hours before first PET scan - Prolonged corticosteroid therapy (> 1 week) for another indication in past 6 months - History of vasculitis or connective tissue disease - Active malignancy |
Matokeo
Hatua za Matokeo ya Msingi
1. Diagnostic accuracy of FDG uptake in the superficial cranial or intrathoracic arteries for the diagnosis of temporal artery biopsy proven GCA amongst patients with suspected GCA [Baseline]
Hatua za Matokeo ya Sekondari
1. Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0. [24 months]
2. Difference in Th1 and Th17 axis cytokines in patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months [24 months]
3. Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens [24 months]
4. Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients [24 months]
5. Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months [24 months]
6. Difference in temporal artery histology between GCA patients with and without thoracic large vessel PET uptake at 0 months [Baseline]
7. Difference in temporal artery histology between GCA patients with and without temporal artery PET uptake at 0 months [Baseline]
