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Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

NCT02134171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-07-25

No results posted yet for this study

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.

Conditions

  • Thrombotic Microangiopathies
  • Thrombotic Thrombocytopenic Purpura

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Paul Coppo, MD, PhD · Assistance Publique

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-10
Primary Completion
2017-07-04
Completion
2017-07-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134171 on ClinicalTrials.gov