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Early Predictive Factors of Cardiac and Cerebral Involvement in TMA (MATRISK)

Primary Purpose

Thrombotic Microangiopathies, Thrombotic Thrombocytopenic Purpura

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biological and imaging investigations

About this trial

This is an interventional diagnostic trial for Thrombotic Microangiopathies focused on measuring Thrombotic microangiopathy,, haemolytic uremic syndrome,, thrombotic thrombocytopenic purpura,, ADAMTS13,, troponin,, plasma exchange.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

Saint Antoine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological investigations

Arm 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.

Outcomes

Primary Outcome Measures

30-day event-free survival

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

Cerebral trouble frequency and type at diagnosis

Comparison of cerebral and cardiac trouble at diagnosis between thrombotic microangiopathies type

Description of cardiac and cerebral sequelae at M6 and reversibility frequency of diagnosis cardiac and cerebral lesions at M6

Determination of cardiac and cerebral sequelae prognostic factors at M6

Full Information

NCT ID

NCT02134171

First Posted

March 24, 2014

Last Updated

July 23, 2019

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02134171

Brief Title

Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

Acronym

MATRISK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

June 10, 2014 (Actual)

Primary Completion Date

July 4, 2017 (Actual)

Study Completion Date

July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombotic Microangiopathies, Thrombotic Thrombocytopenic Purpura

Keywords

Thrombotic microangiopathy,, haemolytic uremic syndrome,, thrombotic thrombocytopenic purpura,, ADAMTS13,, troponin,, plasma exchange.

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biological investigations

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Biological and imaging investigations

Intervention Description

Primary Outcome Measure Information:

Title

30-day event-free survival

Description

Time Frame

At 30 days

Secondary Outcome Measure Information:

Title

Cardiac trouble frequency and type at diagnosis

Time Frame

From day 1 to day 3 after diagnosis

Title

Cerebral trouble frequency and type at diagnosis

Time Frame

From day 1 and day 7 after diagnosis

Title

Comparison of cerebral and cardiac trouble at diagnosis between thrombotic microangiopathies type

Time Frame

Baseline

Title

Description of cardiac and cerebral sequelae at M6 and reversibility frequency of diagnosis cardiac and cerebral lesions at M6

Time Frame

At 6 months

Title

Determination of cardiac and cerebral sequelae prognostic factors at M6

Time Frame

At 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Coppo, MD, PhD

Organizational Affiliation

Assistance Publique

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Antoine

City

Paris

ZIP/Postal Code

75012

Country

France

12. IPD Sharing Statement

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Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

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