CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

NCT03488654 | Terminated

• 1 other identifier: Heart-SLE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lupus Erythematosus, Systemic; Coronary Artery Disease; Myocardial Disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of cardiovascular pathologies identified by CMR in patients with SLE

  at baseline

Interventions

Cardiovascular magnetic resonance DIAGNOSTIC_TEST

CMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with diagnosed SLE

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Coronary Artery Disease; Cardiomyopathies

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Thilo Burkard

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 5, 2018
• Study Start: July 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 5, 2018

Record last verified: 2018-03

Locations

CH (1)