CMR in Patients With Myocarditis

Suspected Acute Myocarditis Clinical Trial

Official title:

Value of CMR Including T1 Mapping in Patients With Acute Myocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962584
• Other study ID #: 150/13
• Status: Completed
• Phase: N/A
• First received: October 4, 2013
• Last updated: December 9, 2015
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Commission: University of Bonn
• Study type: Observational

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myocarditis
• Suspected Acute Myocarditis

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	No
Secondary	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".	No