NCT03470571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

March 13, 2018

Last Update Submit

March 18, 2018

Conditions

Outcome, Fatal

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    Heart failure hospitalization; all cause death; sustained ventricular arrhythmia; recurrent myocarditis; transplantation

    through study completion, an average of 2 years

Interventions

CMRDIAGNOSTIC_TEST

Outcome analysis of CMR features in suspected myocarditis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital, Shapiro Cardiovascular Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • Bernhard B, Tanner G, Garachemani D, Schnyder A, Fischer K, Huber AT, Safarkhanlo Y, Stark AW, Guensch DP, Schutze J, Greulich S, Bastiaansen JAM, Pavlicek-Bahlo M, Benz DC, Kwong RY, Grani C. Predictive value of cardiac magnetic resonance right ventricular longitudinal strain in patients with suspected myocarditis. J Cardiovasc Magn Reson. 2023 Aug 17;25(1):49. doi: 10.1186/s12968-023-00957-6.

    PMID: 37587516DERIVED

  • Bernhard B, Schnyder A, Garachemani D, Fischer K, Tanner G, Safarkhanlo Y, Stark AW, Schutze J, Pavlicek-Bahlo M, Greulich S, Johner C, Wahl A, Benz DC, Kwong RY, Grani C. Prognostic Value of Right Ventricular Function in Patients With Suspected Myocarditis Undergoing Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2023 Jan;16(1):28-41. doi: 10.1016/j.jcmg.2022.08.011. Epub 2022 Oct 19.

    PMID: 36599567DERIVED

  • Fischer K, Obrist SJ, Erne SA, Stark AW, Marggraf M, Kaneko K, Guensch DP, Huber AT, Greulich S, Aghayev A, Steigner M, Blankstein R, Kwong RY, Grani C. Feature Tracking Myocardial Strain Incrementally Improves Prognostication in Myocarditis Beyond Traditional CMR Imaging Features. JACC Cardiovasc Imaging. 2020 Sep;13(9):1891-1901. doi: 10.1016/j.jcmg.2020.04.025. Epub 2020 Jul 15.

    PMID: 32682718DERIVED

  • Grani C, Eichhorn C, Biere L, Kaneko K, Murthy VL, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Comparison of myocardial fibrosis quantification methods by cardiovascular magnetic resonance imaging for risk stratification of patients with suspected myocarditis. J Cardiovasc Magn Reson. 2019 Feb 28;21(1):14. doi: 10.1186/s12968-019-0520-0.

    PMID: 30813942DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 20, 2018

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

February 1, 2018

Last Updated

March 20, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)