Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus

NCT ID: NCT04580108

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

446 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-03

Study Completion Date

2019-06-26

Brief Summary

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Identification of biological markers able to better stratify cardiovascular risks in systemic lupus erythematosus patients is needed. We aimed to determine whether serum cardiac troponin T levels measured with a highly sensitive assay (HS-cTnT) may predict cardiovascular events in systemic lupus erythematosus.

Detailed Description

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Cardiac Troponin (cTnT) is a marker of myocyte necrosis and injury in the early phase of acute myocardial infarction. Measured with high-sensitivity (HS) assays, HS-cTnT has proven predictive value for coronary heart disease, heart failure, and mortality in the general population at apparent low-risk for cardiovascular events. In a previous study, our group showed that HS-cTnT concentration was associated with subclinical atherosclerosis in systemic lupus erythematosus patients. The aim of this study was to determine whether HS-cTnT was associated with incident cardiovascular events in systemic lupus erythematosus

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with systemic lupus erythematosus

Patients with systemic lupus erythematosus enrolled in the PLUS cohort between 2007 and 2010

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient with a systemic lupus erythematosus

Exclusion Criteria

* Inadequate follow-up period (\< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karim Sacré, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

GH Bichat-Claude Bernard, Paris, France, 75018

Locations

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Bichat Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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NI17026J

Identifier Type: -

Identifier Source: org_study_id

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