CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03488654
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 53
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic; Coronary Artery Disease; Myocardial Disease	Diagnostic Test: Cardiovascular magnetic resonance

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: The Heart in Systemic Lupus Erythematosus - a Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography
• Actual Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Outcome Measures

Primary Outcome Measures

1. Prevalence of cardiovascular pathologies identified by CMR in patients with SLE [at baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Thilo Burkard, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03488654
• Other Study ID Numbers: Heart-SLE
• First Posted: Apr 5, 2018
• Last Update Posted: Apr 5, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Coronary Artery Disease; Cardiomyopathies; Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Apr 5, 2018