NCT04580108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
446

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2012

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

May 1, 2020

Enrollment Period

4.5 years

First QC Date

May 19, 2020

Last Update Submit

October 7, 2020

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusCardiovascular riskBiomarkersTroponin T

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was the occurrence of cardiovascular events over follow-up.

    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

    Up to 10 years

Study Arms (1)

Patients with systemic lupus erythematosus

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with systemic lupus erythematosus

You may qualify if:

  • Patient with a systemic lupus erythematosus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat Hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Karim Sacré, MD, PhD

    GH Bichat-Claude Bernard, Paris, France, 75018

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

October 8, 2020

Study Start

July 3, 2007

Primary Completion

January 17, 2012

Study Completion

June 26, 2019

Last Updated

October 8, 2020

Record last verified: 2020-05

Locations

FR(1)