CMR in Patients With Myocarditis | NCT01962584

Studies
CMR in Patients With Myocarditis

NCT01962584

Sponsor

University Hospital, Bonn

Status

Completed

Last Update Posted

Dec 11, 2015Estimated

Enrollment

66Actual

Phase

Not provided

Conditions

Suspected Acute Myocarditis

Interventions

Not provided

Countries

Germany

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 4, 2013

First Submission Date that Met QC Criteria

Oct 9, 2013

First Posted Date

Oct 14, 2013Estimated

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

Dec 9, 2015

Last Update Posted Date

Dec 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claas P. Naehle, section chief cardicvascular imaging, University Hospital, BonnPrincipal Investigator

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Not provided

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

To evaluate the additive values of T1 mapping in patients with acute myocarditis.

Detailed Description

Cardiac magnetic resonance (CMR) is an established non-invasive diagnostic tool for acute and chronic myocarditis. Established CMR criteria for diagnosing myocarditis are edema on black-blood T2-weighted imaging, relative contrast enhancement seen on T1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis.

Recently, tissue characterization based on calculation of myocardial T1 relaxation time (T1 mapping) as well as T1-derived extracellular volume fraction has become available. Recently, reference values for myocardial T1 relaxation times at 3T for healthy volunteers were published for CMR. However, to date no comprehensive data for multiparametric CMR in patients with suspected myocarditis at 3 Tesla is available. Therefore, the purpose of this prospective study was to evaluate the diagnostic value of CMR at 3T in patients with suspected acute myocarditis using a multiparametric CMR approach including T1 mapping as novel tool for tissue characterization.

CMR will be performed within 7 days after hospital admission for "suspected acute myocarditis".

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAM		patients with suspected acute myocarditis
HC		Healthy controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
T1 relaxation times	quantification of T1 relaxation times	time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".

Secondary Outcomes

Measure	Description	Time Frame
Extracellular volume (ECV)	calculation of extracellular volume based on T1 relaxation time	time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with suspected acute myocarditis and otherwise unremarkable cardiac history

Exclusion Criteria:

exclusion of CAD in invasive coronary angiography
pregnancy
contraindications for MR imaging

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with suspected acute myocarditis and otherwise unremarkable cardiac history exclusion of CAD in invasive coronary angiography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Bonn		Bonn	North Rhine-Westphalia	53127	Germany