Outcome, FatalCMRMyoNCT03470571
CMR Features in Patients With Suspected Myocarditis
An observational study of Outcome, Fatal, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outcome, Fatal
- What is being tested?
- CMR
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question
Who cannot join
- evidence of coronary artery disease
- hypertrophic cardiomyopathy
- arrhythmogenic right ventricular cardiomyopathy
- cardiac sarcoidosis
- cardiac amyloidosis
- takotsubo cardiomyopathy
Show all 12Show fewer
- constrictive pericarditis
- Loeffler endocarditis
- ventricular non-compaction
- cardiac tumor
- pulmonary embolism
- severe valve disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital, Shapiro Cardiovascular Center
Boston, Massachusetts, 02115
About this study
Official title: Predictive Value of CMR Features in Patients With Suspected Myocarditis
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.
- Conditions
- Outcome, Fatal
- Being tested
- CMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMRDiagnostic test
Outcome analysis of CMR features in suspected myocarditis patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Heart failure hospitalization; all cause death; sustained ventricular arrhythmia; recurrent myocarditis; transplantation
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jun 2016
- Primary completion1 Apr 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Outcome, FatalStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Y. Kwong, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470571
- Sponsor's protocol ID
- CMR Myocarditis
- Acronym
- CMRMyo
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37587516Bernhard 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.
PubMed 36599567Fischer 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.
PubMed 32682718Grani 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.
PubMed 30813942
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of CMR Features in Patients With Suspected Myocarditis
- ClinicalTrials.gov ID
- NCT03470571
- Acronym / sponsor ID
- CMRMyo / CMR Myocarditis
- Conditions
- Outcome, Fatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question
Key exclusion criteria (12 listed)
- evidence of coronary artery disease
- hypertrophic cardiomyopathy
- arrhythmogenic right ventricular cardiomyopathy
- cardiac sarcoidosis
- cardiac amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMROutcome analysis of CMR features in suspected myocarditis patients | Diagnostic test | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 37587516Bernhard 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.
- Derived from this study: PubMed 36599567Bernhard 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.
- Derived from this study: PubMed 32682718Fischer 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.
- Derived from this study: PubMed 30813942Grani 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.
- Individual participant dataSharing planned: No
Related trials for Outcome, Fatal
Active, not recruitingObservational study
Nut Consumption and Prevention of Non-communicable Diseases: A Global Individual Participant Data Meta-analysis
Diabetes (DM), Cardio Vascular Disease
RecruitingObservational study
Russian Registry of Surgical OutcomeS
Surgery, Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome, Fatal, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470571, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.