CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

March 28, 2018 updated by: University Hospital, Basel, Switzerland

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with diagnosed SLE

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of cardiovascular pathologies identified by CMR in patients with SLE
Time Frame: at baseline
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heart-SLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Cardiovascular magnetic resonance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe