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NCT03488654 Clinical Trial

CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

Coronary Artery Disease Clinical Trial

Official title:
The Heart in Systemic Lupus Erythematosus - a Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03488654
Other study ID # Heart-SLE
Secondary ID
Status Terminated
Phase
First received March 28, 2018
Last updated March 28, 2018
Start date July 2010
Est. completion date December 2014

Study information
Verified date March 2018
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diagnosis of SLE, as defined by the American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Cardiovascular magnetic resonance
CMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences

Locations
Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of cardiovascular pathologies identified by CMR in patients with SLE at baseline
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