Systemic Lupus ErythematosusTROPOPLUSNCT04580108
Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 446 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2007to 26 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with systemic lupus erythematosus
Who may be able to join
- Patient with a systemic lupus erythematosus
Who cannot join
- Inadequate follow-up period (< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, Cardiovascular risk, Biomarkers, Troponin T
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with systemic lupus erythematosus | Patients with systemic lupus erythematosus enrolled in the PLUS cohort between 2007 and 2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start3 Jul 2007
- Primary completion17 Jan 2012
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Karim Sacré, MD, PhD, Principal investigator, GH Bichat-Claude Bernard, Paris, France, 75018
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580108
- Sponsor's protocol ID
- NI17026J
- Acronym
- TROPOPLUS
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04580108
- Acronym / sponsor ID
- TROPOPLUS / NI17026J
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, Cardiovascular risk, Biomarkers, Troponin T
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 3 Jul 2007 (actual)
- Primary completion
- 17 Jan 2012 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with systemic lupus erythematosus | – | –Patients with systemic lupus erythematosus enrolled in the PLUS cohort between 2007 and 2010 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus
Key inclusion criteria (1 listed)
- Patient with a systemic lupus erythematosus
Key exclusion criteria (1 listed)
- Inadequate follow-up period (< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome was the occurrence of cardiovascular events over follow-up.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Sacré, MD, PhD principal investigator
GH Bichat-Claude Bernard, Paris, France, 75018
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the occurrence of cardiovascular events over follow-up. (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.