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CMR Features in Patients With Suspected Myocarditis (CMRMyo)

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: NCT03470571
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital

Brief Summary:
Presentation of myocarditis is heterogeneous, often ranges from being asymptomatic, to chest pain, dyspnoea, palpitations, and even sudden cardiac death. Diagnosing myocarditis is challenging with no current uniform clinical gold-standard. CMR is a key investigative tool, however the predictive value of CMR features is unknown. In this study we assess 670 consecutive patients with suspected myocarditis who were referred for CMR between 2002 and 2015 at the BWH. CMR features such as late gadolinium sizing, T1 mapping, extracellular volume fraction assessment, strain analysis (feature tracking), clinical data, labortory tetsings and electrocardiogramm are linked to the outcome in order to assess its predictive value.

Condition or disease Intervention/treatment
Outcome, Fatal Diagnostic Test: CMR

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Study Type : Observational
Actual Enrollment : 670 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Value of CMR Features in Patients With Suspected Myocarditis
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: CMR
    Outcome analysis of CMR features in suspected myocarditis patients


Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: through study completion, an average of 2 years ]
    Heart failure hospitalization; all cause death; sustained ventricular arrhythmia; recurrent myocarditis; transplantation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study includes consecutive patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question between December 2002 and December 2015 at our center.
Criteria

Inclusion Criteria:

  • patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question

Exclusion criteria

  • evidence of coronary artery disease
  • hypertrophic cardiomyopathy
  • arrhythmogenic right ventricular cardiomyopathy
  • cardiac sarcoidosis
  • cardiac amyloidosis
  • takotsubo cardiomyopathy
  • constrictive pericarditis
  • Loeffler endocarditis
  • ventricular non-compaction
  • cardiac tumor
  • pulmonary embolism
  • severe valve disease

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): NCT03470571


Locations
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United States, Massachusetts
Brigham and Women's Hospital, Shapiro Cardiovascular Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raymond Y. Kwong, MD, Associate Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03470571     History of Changes
Other Study ID Numbers: CMR Myocarditis
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases