Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134171
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Thrombotic Microangiopathies Thrombotic Thrombocytopenic Purpura Other: Biological and imaging investigations Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
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 : June 10, 2014
Actual Primary Completion Date : July 4, 2017
Actual Study Completion Date : July 30, 2017


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134171


Locations
Layout table for location information
France
Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Paul Coppo, MD, PhD Assistance Publique

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02134171    
Other Study ID Numbers: p120118
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Thrombotic microangiopathy,
haemolytic uremic syndrome,
thrombotic thrombocytopenic purpura,
ADAMTS13,
troponin,
plasma exchange.
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Thrombotic Microangiopathies
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Thrombophilia
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs