NCT03348306

Multi-organ Screening for Asymptomatic Ischaemia in Antiphospholipid Syndrome

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction 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. Objectives 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.

Conditions

• Antiphospholipid Syndrome

Interventions

Type	Name	Description
DEVICE	MRI	Brain and cardiac MRI in one time with gadolinium injection.
BIOLOGICAL	Blood sample collection	A blood sampling is also collected for hematocrit measure.

Timeline

• Start date: 2018-07-20
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2017-11-20
• Last updated: 2022-02-03

Locations

1 site across 1 country: France