Thrombotic Thrombocytopenic Purpura Clinical Trial
Official title:
Identification of Early Predictive Factors of Cardiac and Cerebral Involvement in Thrombotic Microangiopathies
The aim of this study is to determine the frequency of cardiac and cerebral involvements in
patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed
for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral
involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on
diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy
at the acute phase.
The primary outcome measurement is the event free survival at day 30, as defined by death,
myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase
in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three
daily analyses performed after TMA diagnosis.
After TMA diagnosis, patients will be treated in emergency according to standard National
recommendations. Patient will be included in the study as soon as the diagnosis of TMA is
performed.
From day 1 to day 3, specific blood tests will be performed (serum troponin Ic and brain
natriuretic peptide [BNP]). A cardiac ultrasonography within the 4 first days and a cerebral
MRI within the first 7 days after TMA diagnosis will be performed.
Our hypothesis is that an increased serum troponin Ic level on diagnosis (> 0.2 ng/ml) is a
predictive feature of cardiac events or worsening at the acute phase.
At 6 months, a control cardiac ultrasonography and cerebral MRI will be performed in patients
with cardiac and/or cerebral involvement on diagnosis.
122 patients are expected to be included among 30 recruiting centres in France. The total
duration of inclusions is 2.5 years, and the total duration of the study is of 3 years.
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