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

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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

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE June 10, 2014
Actual Primary Completion Date July 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • Cardiac trouble frequency and type at diagnosis [ Time Frame: From day 1 to day 3 after diagnosis ]
  • Cerebral trouble frequency and type at diagnosis [ Time Frame: From day 1 and day 7 after diagnosis ]
  • Comparison of cerebral and cardiac trouble at diagnosis between thrombotic microangiopathies type [ Time Frame: Baseline ]
  • Description of cardiac and cerebral sequelae at M6 and reversibility frequency of diagnosis cardiac and cerebral lesions at M6 [ Time Frame: At 6 months ]
  • Determination of cardiac and cerebral sequelae prognostic factors at M6 [ Time Frame: At 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Predictive Factors of Cardiac and Cerebral Involvement in TMA
Official Title  ICMJE Identification of Early Predictive Factors of Cardiac and Cerebral Involvement in Thrombotic Microangiopathies
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Thrombotic Microangiopathies
  • Thrombotic Thrombocytopenic Purpura
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Biological and imaging investigations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2017)
119
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
116
Actual Study Completion Date  ICMJE July 30, 2017
Actual Primary Completion Date July 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134171
Other Study ID Numbers  ICMJE p120118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Coppo, MD, PhD Assistance Publique
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP