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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03470571
Other study ID # CMR Myocarditis
Secondary ID
Status Completed
Phase
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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