Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

Not Applicable

Completed

• Conditions: Thrombotic Thrombocytopenic Purpura; Thrombotic Microangiopathies
• Interventions: Other: Biological and imaging investigations

• Registration Number: NCT02134171
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-09
• Study Start: 2014-06-10
• Primary Completion: 2017-07-04
• Study Completion: 2017-07-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• A diagnosis of thrombotic microangiopathy on the following criteria :
• A microangiopathic haemolytic anaemia (Hb< 12 g/dl, with presence of schistocytes on blood smear);
• A thrombocytopenia <150 G/l;
• No associated (precipitating) disease (HIV infection, cancer, chemotherapy, transplantation) or pregnancy;
• A written consent obtained from the patient, or from a relative for patients unable to provide the informed consent (because of cerebral involvement for example);
• Affiliation at the social insurance regimen.
• Major person

Exclusion Criteria

• A TMA associated with an associated condition: infection with HIV (HIV) in AIDS stage, , chemotherapy, malignancy, transplantation, or pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological investigations	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.

Primary Outcome Measures

Name	Time	Method
30-day event-free survival	At 30 days	Events include death or myocardial infarction, arrhythmia, cerebral involvement and exacerbation. Serum troponin Ic is assessed daily the 3 first days following diagnosis. Cardiac ultrasonography is performed within the 4 days following diagnosis and cerebral MRI is performed within the 7 days following the diagnosis.

Secondary Outcome Measures

Name	Time	Method
Cardiac trouble frequency and type at diagnosis	From day 1 to day 3 after diagnosis
Cerebral trouble frequency and type at diagnosis	From day 1 and day 7 after diagnosis
Comparison of cerebral and cardiac trouble at diagnosis between thrombotic microangiopathies type	Baseline
Description of cardiac and cerebral sequelae at M6 and reversibility frequency of diagnosis cardiac and cerebral lesions at M6	At 6 months
Determination of cardiac and cerebral sequelae prognostic factors at M6	At 6 months

Trial Locations

Locations (1)

Saint Antoine; 🇫🇷 Paris, France