CMR-Lupus Comprehensive Approach by Cardiovascular Magnet... | NCT03488654

Studies
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

NCT03488654

Sponsor

University Hospital, Basel, Switzerland

Status

Terminated

Last Update Posted

Apr 5, 2018Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Lupus Erythematosus, Systemic
Coronary Artery Disease
Myocardial Disease

Interventions

Cardiovascular magnetic resonance

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitement problems as single centre study

Expanded Access Info

Start Date

Jul 2010Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 28, 2018

First Submission Date that Met QC Criteria

Mar 28, 2018

First Posted Date

Apr 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiovascular magnetic resonance	Diagnostic Test	CMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with diagnosed SLE

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thilo Burkard	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel		4031	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic
D003324	Coronary Artery Disease
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided