NCT02134171

Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

Identification of Early Predictive Factors of Cardiac and Cerebral Involvement in Thrombotic Microangiopathies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thrombotic Microangiopathies
• Thrombotic Thrombocytopenic Purpura

Interventions

Type	Name	Description
OTHER	Biological and imaging investigations	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.

Timeline

• Start date: 2014-06-10
• Primary completion: 2017-07-04
• Completion: 2017-07-30
• First posted: 2014-05-09
• Last updated: 2019-07-25

Locations

1 site across 1 country: France