Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome (COBRA)
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|ClinicalTrials.gov Identifier: NCT03348306|
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : October 10, 2018
AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the presence of persistent thrombosis or obstetric manifestations together with the presence of persistent antiphospholipid antibodies (aPL). Patients are young and at high risk of recurrence. The current challenge is the identification of patients at high risk of organ damage that directly impact morbidity and mortality.
Small vessels thrombosis can be asymptomatic but detectable by MRI. Apart from APS, it was shown that the detection of asymptomatic ischemic events identify patients at risk for symptomatic ischemic events. Demonstrating this in patients with APS would prevent thrombotic complications.
The investigators' hypothesis is that a significant proportion of patients with APS would have asymptomatic organ involvement.
The primary objective is to determine the frequency of asymptomatic target organ (s) (heart, brain, kidney) in APS patients.
Secondary objectives are (i) to determine the frequency of each type of MRI abnormality, (ii) to identify the factors associated with asymptomatic target organ lesion, (iii) to describe the parameters of echocardiography associated with cerebral and cardiac MRI, and (iv) to assess the feasibility of a one-time cardiovascular and brain MRI.
Methods and analysis
This is a prospective interventional, cross-sectional, non-randomized, monocentric clinical study. The investigators expect to include 50 consecutive patients with APS followed in the department of Vascular Medicine at Nancy University Hospital.
Within 15 days post-inclusion, a one-time cardiac and cerebral MRI will be performed. For each patient, the number of target organs involvements will be calculated and the frequencies will be compared by Fisher or chi-2 tests.
|Condition or disease||Intervention/treatment||Phase|
|Antiphospholipid Syndrome||Device: MRI Biological: Blood sample collection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessement of a Multi-organ Screening Procedure for the Detection of Pre-clinical Ischaemia in Antiphospholipid Syndrome The COBRA Study (CardiO-Brain Renal Involvement in Antiphospholipid Syndrome)|
|Actual Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
|Experimental: All patients||
Brain and cardiac MRI in one time with gadolinium injection.
Biological: Blood sample collection
A blood sampling is also collected for hematocrit measure.
- A brain or cardiac involvement will be defined by the identification of specific criteria visible by MRI. [ Time Frame: Through study completion, in average of 24 months ]
- Renal damage will be defined by the identification of a microalbuminuria> 30mg / L. [ Time Frame: Through study completion, in average of 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348306
|Contact: Stéphane ZUILYfirstname.lastname@example.org|
|Contact: Denis WAHLemail@example.com|
|CHRU Nancy Brabois||Recruiting|
|Nancy, France, 54000|
|Contact: Virginie DUFROST|
|Principal Investigator:||Virginie DUFROST||Nancy Academic Hospital|