Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03348306
Brief 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.
Study:
NCT03348306
Study Brief:
Protocol Section:
NCT03348306