Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609668
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Pilot Study Evaluating the Value of Thrombomodulin in Ruling Out the Diagnosis of Giant Cell Arteritis GCA in Pseudo Rheumatoid Arthritis PRA THROPIQ
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Study Evaluating the Value of Thrombomodulin in Ruling Out the Diagnosis of Giant Cell Arteritis GCA in Pseudo Rheumatoid Arthritis PRA THROPIQ
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THROPIQ
Brief Summary:
Pseudo-polyarthritis rheumatica PPR is a common inflammatory condition after the age of 50 characterized by pain in the scapular shoulder and pelvic hip girdles PPR is most often isolated but can sometimes be associated with giant cell arteritis GCA also known as Hortonamp39s disease an inflammation of the large vessels The main symptoms of GCA are headaches jaw claudication cramps visual disturbances hyperesthesia of the scalp andor a significant inflammatory syndrome inflammation in the blood It is estimated that around 20 of patients with PPR also present with GCA
GCA requires higher doses of corticosteroids than in the case of isolated PPR to avoid complications resulting from blood vessel damage stroke blindness secondary to vascular damage So when a patient is diagnosed with PPR the doctor looks for symptoms suggestive of CAG If they are present further investigations are carried out to confirm or refute the diagnosis of CAG and to adapt treatments if necessary However the complementary investigations currently available to diagnose GCA are costly irradiating angiography-CT angiography-MRI and PET scans or invasive temporal artery biopsy TAB
The aim of this study is to search for biological blood markers that would indicate the presence of GCA in the presence of PPR symptoms Ultimately if markers are identified this would make it possible to replace current examinations with a blood test For this study investigators chose to explore the interest of thrombomodulin Thrombomodulin is a protein that is increased in the blood in the event of vascular aggression and therefore seems to be a good candidate for distinguishing isolated PPR from PPR associated with ACG
GCA requires higher doses of corticosteroids than in the case of isolated PPR to avoid complications resulting from blood vessel damage stroke blindness secondary to vascular damage So when a patient is diagnosed with PPR the doctor looks for symptoms suggestive of CAG If they are present further investigations are carried out to confirm or refute the diagnosis of CAG and to adapt treatments if necessary However the complementary investigations currently available to diagnose GCA are costly irradiating angiography-CT angiography-MRI and PET scans or invasive temporal artery biopsy TAB
The aim of this study is to search for biological blood markers that would indicate the presence of GCA in the presence of PPR symptoms Ultimately if markers are identified this would make it possible to replace current examinations with a blood test For this study investigators chose to explore the interest of thrombomodulin Thrombomodulin is a protein that is increased in the blood in the event of vascular aggression and therefore seems to be a good candidate for distinguishing isolated PPR from PPR associated with ACG
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None