Early Predictive Factors of Cardiac and Cerebral Involvement in TMA

NCT02134171 | Completed

• 1 other identifier: p120118
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombotic Microangiopathies; Thrombotic Thrombocytopenic Purpura

Keywords

Thrombotic microangiopathy,; haemolytic uremic syndrome,; thrombotic thrombocytopenic purpura,; ADAMTS13,; troponin,; plasma exchange.

Outcome Measures

Primary Outcomes (1)

• 30-day event-free survival

  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.

  At 30 days

Secondary Outcomes (5)

• Cardiac trouble frequency and type at diagnosis

  From day 1 to day 3 after diagnosis

• Cerebral trouble frequency and type at diagnosis

  From day 1 and day 7 after diagnosis

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

  Baseline

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

  At 6 months

• Determination of cardiac and cerebral sequelae prognostic factors at M6

  At 6 months

Study Arms (1)

Biological investigations

EXPERIMENTAL

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

Interventions

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.

Biological investigations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A TMA associated with an associated condition: infection with HIV (HIV) in AIDS stage, , chemotherapy, malignancy, transplantation, or pregnancy.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Thrombotic Microangiopathies; Purpura, Thrombotic Thrombocytopenic

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Paul Coppo, MD, PhD

  Assistance Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: May 9, 2014
• Study Start: June 10, 2014
• Primary Completion: July 4, 2017
• Study Completion: July 30, 2017
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

FR (1)