CMR Features in Patients With Suspected Myocarditis

Outcome, Fatal Clinical Trial

— CMRMyo  

Official title:

Predictive Value of CMR Features in Patients With Suspected Myocarditis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470571
• Other study ID #: CMR Myocarditis
• Status: Completed
• First received: March 13, 2018
• Last updated: March 18, 2018
• Start date: June 1, 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: February 1, 2018
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocarditis
• Outcome, Fatal

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, Shapiro Cardiovascular Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	Heart failure hospitalization; all cause death; sustained ventricular arrhythmia; recurrent myocarditis; transplantation	through study completion, an average of 2 years