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

Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

Sponsors

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Source 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.

Overall Status Completed
Start Date June 10, 2014
Completion Date July 30, 2017
Primary Completion Date July 4, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
30-day event-free survival At 30 days
Secondary Outcome
Measure Time Frame
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
Enrollment 119
Condition
Intervention

Intervention type: Other

Intervention name: Biological and imaging investigations

Description: 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 group label: Biological investigations

Eligibility

Criteria:

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Paul Coppo, MD, PhD Principal Investigator Assistance Publique
Location
facility Saint Antoine
Location Countries

France

Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Biological investigations

Arm group type: Experimental

Description: 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.

Acronym MATRISK
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov