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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04580108

Acronym

TROPOPLUS

Enrollment

446

Registered

2020-10-08

Start date

2007-07-03

Completion date

2019-06-26

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus, Cardiovascular risk, Biomarkers, Troponin T

Brief summary

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The primary outcome was the occurrence of cardiovascular events over follow-up.	Up to 10 years	Incidents cardiovascular events (CVE) were ascertained by physician interview using a standardized questionnaire and through examination of medical records. cardiovascular events included coronary heart disease, stroke, revascularization procedure for other atherosclerotic cardiovascular diseases and sudden cardiac death. Coronary heart disease was defined as a history of angina, coronary revascularization, or myocardial infarction. All CVE that occurred through March 2019 were considered for analysis

Countries

France

Outcome results