Lupus Erythematosus, SystemicNCT03488654
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography
An observational study of Lupus Erythematosus, Systemic and Coronary Artery Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, Coronary Artery Disease, Myocardial Disease
- What is being tested?
- Cardiovascular magnetic resonance
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with diagnosed SLE
Who may be able to join
- diagnosis of SLE, as defined by the American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus
Who cannot join
- age under 18 years
- known coronary artery disease
- impaired renal function with an estimated glomerular filtration rate less than 30 ml/min, estimated by the Modification of Diet in Renal Disease Study Group (MDRD) formula (45)
- devices as pacemakers, implantable cardioverter-defibrillators, insulin pumps and others
- metallic foreign bodies in the eyes, ferromagnetic implants labeled MR unsafe
- allergy against CMR contrast media or adenosine
- presence of chronic atrial fibrillation, 2nd or 3rd degree Atrioventricular (AV)-block, trifascicular block, asthma and severe chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Heart in Systemic Lupus Erythematosus - a Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography
In systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. We studied whether a comprehensive cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart disease in SLE patients without known CAD
- Being tested
- Cardiovascular magnetic resonance
- Medical subject headings
- Lupus Erythematosus, Systemic, Coronary Artery Disease, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular magnetic resonanceDiagnostic test
CMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiovascular pathologies identified by CMR in patients with SLE
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Recruitement problems as single centre study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thilo Burkard, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488654
- Sponsor's protocol ID
- Heart-SLE
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heart in Systemic Lupus Erythematosus - a Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography
- ClinicalTrials.gov ID
- NCT03488654
- Acronym / sponsor ID
- Heart-SLE
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitement problems as single centre study
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Apr 2018 (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.
In systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. We studied whether a comprehensive cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart disease in SLE patients without known CAD
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diagnosed SLE
Key inclusion criteria (1 listed)
- diagnosis of SLE, as defined by the American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus
Key exclusion criteria (7 listed)
- age under 18 years
- known coronary artery disease
- impaired renal function with an estimated glomerular filtration rate less than 30 ml/min, estimated by the Modification of Diet in Renal Disease Study Group (MDRD) formula (45)
- devices as pacemakers, implantable cardioverter-defibrillators, insulin pumps and others
- metallic foreign bodies in the eyes, ferromagnetic implants labeled MR unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular magnetic resonanceCMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences | Diagnostic test | – |
Primary outcome
Prevalence of cardiovascular pathologies identified by CMR in patients with SLE
Time frame: at baseline
Results and safety
The study was stopped early (reason given: Recruitement problems as single centre study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Thilo Burkard principal investigator
University Hospital, Basel, Switzerland
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 Lupus Erythematosus, Systemic and Coronary Artery Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 Switzerland. 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 was stopped early (reason given: Recruitement problems as single centre study). Results are not available in the source record.
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?
Prevalence of cardiovascular pathologies identified by CMR in patients with SLE (time frame: at baseline). 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 5 Apr 2018.