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Completed

NCT Number: NCT02134171

Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological and imaging investigations

Other

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 outcomes

  1. 30-day event-free survival

    Time frame: 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 outcomes

  1. Cardiac trouble frequency and type at diagnosis

    Time frame: From day 1 to day 3 after diagnosis

  2. Cerebral trouble frequency and type at diagnosis

    Time frame: From day 1 and day 7 after diagnosis

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

    Time frame: Baseline

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

    Time frame: At 6 months

  5. Determination of cardiac and cerebral sequelae prognostic factors at M6

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MATRISK

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 9, 2014
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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