MATRISK: Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT02134171

Collaborator

(none)

119

Enrollment

Location

Arm

37.7

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombotic Microangiopathies Thrombotic Thrombocytopenic Purpura	Other: Biological and imaging investigations	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

119 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 10, 2014

Actual Primary Completion Date :

Jul 4, 2017

Actual Study Completion Date :

Jul 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biological 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.	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.

Arm

Intervention/Treatment

Experimental: Biological investigations

Other: Biological and imaging investigations

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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