Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

NCT ID: NCT02134171

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-10
• Study Completion Date: 2017-07-30

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.

Conditions

Thrombotic Microangiopathies; Thrombotic Thrombocytopenic Purpura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biological and imaging investigations

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Coppo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Locations

Saint Antoine

Paris, , France

Countries

France

Other Identifiers

p120118

Identifier Type: -

Identifier Source: org_study_id