CMR in Patients With Myocarditis

NCT ID: NCT01962584

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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".

Conditions

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Suspected Acute Myocarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SAM

patients with suspected acute myocarditis

No interventions assigned to this group

HC

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Claas P. Naehle

section chief cardicvascular imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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150/13

Identifier Type: -

Identifier Source: org_study_id