ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 33 for:    "Myocarditis"

CMR in Patients With Myocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01962584
Recruitment Status : Completed
First Posted : October 14, 2013
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Claas P. Naehle, University Hospital, Bonn

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

Condition or disease
Suspected 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".


Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Value of CMR Including T1 Mapping in Patients With Acute Myocarditis
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
SAM
patients with suspected acute myocarditis
HC
Healthy controls



Primary Outcome Measures :
  1. T1 relaxation times [ Time Frame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis". ]
    quantification of T1 relaxation times


Secondary Outcome Measures :
  1. Extracellular volume (ECV) [ Time Frame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis". ]
    calculation of extracellular volume based on T1 relaxation time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with suspected acute myocarditis and otherwise unremarkable cardiac history exclusion of CAD in invasive coronary angiography
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962584


Locations
Germany
University of Bonn
Bonn, NRW, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn

Responsible Party: Claas P. Naehle, section chief cardicvascular imaging, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01962584     History of Changes
Other Study ID Numbers: 150/13
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases