MyocarditisNCT02299856
Cardiac Magnetic Resonance in Acute Myocarditis
An observational study of Myocarditis, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the Lake Louise Criteria (two of three criteria have to be positive in order to establish the diagnosis). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocarditis
- What is being tested?
- Cardiac magnetic resonance scan
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Sep 2015
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients are included in the myocarditis group if they showed clinical evidence of acute myocarditis(acute chest pain, history of viral infection, elevated white blood cell count, ECG changes and/or elevated troponin).
Who may be able to join
- No past medical history of cardiac disease.
- No cardiovascular risk factors (e.g. diabetes or hypertension)
Who cannot join
- Contraindications for cardiac MR
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Bonn, Dept. of Radiology
Bonn, North Rhine-Westphalia, 53127
About this study
Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the Lake Louise Criteria (two of three criteria have to be positive in order to establish the diagnosis). Although these criteria are accepted and widely used in clinical routine, several disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume fraction (ECV) and myocardial strain analysis have the potential to complement or even replace some of the Lake Louise Criteria and further enhance the diagnostic performance of cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with acute myocarditis.
- Conditions
- Myocarditis
- Being tested
- Cardiac magnetic resonance scan
- Keywords
- Magnetic Resonance Imaging, Diagnostic Imaging
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance scanOther
| Study group | Role | What they receive |
|---|---|---|
| Myocarditis | Patients with strong clinical evidence for acute myocarditis (recent infection, elevated troponin and white blood cell count). Receives: Other: Cardiac magnetic resonance scan | |
| Healthy Controls | Healthy volunteers without any signs of cardiac disease. Receives: Other: Cardiac magnetic resonance scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial T1 relaxation time
Changes in myocardial T1 relaxation time is of interest in patients with acute myocarditis. T1 relaxation times will be directly obtained from the T1 maps through ROI analysis. T1 maps will be analyzed using a segmental approach. T1 relaxation times are given in [ms].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Myocardial T2 relaxation time
Changes in myocardial T2 relaxation time is of interest in patients with acute myocarditis. T2 relaxation times will be directly obtained from T2 maps through ROI analysis. T2 maps will be analyzed using a segmental approach. T2 relaxation times are given in [ms].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Myocardial ECV measurements
Changes in myocardial ECV parameters is of interest in patients with acute myocarditis. Hematocrit corrected ECV will be calculated using pre- and post-contrast T1 values for myocardium and blood pool using following formula:
ECV= (1⁄T1 "myocardium post contrast"-1⁄T1 "myocadium pre contrast")/(1⁄T1 "blood post contrast"-1⁄ T1 "blood pre contrast") x (1-hematocrit).
ECV is given in percentage.
Measured: Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain analysis (focussed on longitudinal strain)
Changes in longitudinal strain as determined by echocardiography has been described in patient with acute myocarditis. In our study longitudinal strain is measured using feature tracking, which allows for strain calculation from standard MR cine datasets.
Measured: Measurement will be performed within 2 weeks after MRI scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claas P. Naehle, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299856
- Sponsor's protocol ID
- 150/13.2
- Status last verified
- Dec 2015
- First submitted
- 13 Nov 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Luetkens JA, Doerner J, Thomas DK, Dabir D, Gieseke J, Sprinkart AM, Fimmers R, Stehning C, Homsi R, Schwab JO, Schild H, Naehle CP. Acute myocarditis: multiparametric cardiac MR imaging. Radiology. 2014 Nov;273(2):383-92. doi: 10.1148/radiol.14132540. Epub 2014 Jun 6.
PubMed 24910904Luetkens JA, Homsi R, Sprinkart AM, Doerner J, Dabir D, Kuetting DL, Block W, Andrie R, Stehning C, Fimmers R, Gieseke J, Thomas DK, Schild HH, Naehle CP. Incremental value of quantitative CMR including parametric mapping for the diagnosis of acute myocarditis. Eur Heart J Cardiovasc Imaging. 2016 Feb;17(2):154-61. doi: 10.1093/ehjci/jev246. Epub 2015 Oct 16.
PubMed 26476398
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance in Acute Myocarditis
- ClinicalTrials.gov ID
- NCT02299856
- Acronym / sponsor ID
- 150/13.2
- Conditions
- Myocarditis
- Keywords
- Magnetic Resonance Imaging, Diagnostic Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the Lake Louise Criteria (two of three criteria have to be positive in order to establish the diagnosis). Although these criteria are accepted and widely used in clinical routine, several disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume fraction (ECV) and myocardial strain analysis have the potential to complement or even replace some of the Lake Louise Criteria and further enhance the diagnostic performance of cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with acute myocarditis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocarditis | – | Other: Cardiac magnetic resonance scanPatients with strong clinical evidence for acute myocarditis (recent infection, elevated troponin and white blood cell count). |
| Healthy Controls | – | Other: Cardiac magnetic resonance scanHealthy volunteers without any signs of cardiac disease. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are included in the myocarditis group if they showed clinical evidence of acute myocarditis(acute chest pain, history of viral infection, elevated white blood cell count, ECG changes and/or elevated troponin).
Key inclusion criteria (2 listed)
- No past medical history of cardiac disease.
- No cardiovascular risk factors (e.g. diabetes or hypertension)
Key exclusion criteria (1 listed)
- Contraindications for cardiac MR
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 |
|---|---|---|
| Cardiac magnetic resonance scan | Other | Healthy Controls, Myocarditis |
Primary outcome
Myocardial T1 relaxation time
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Changes in myocardial T1 relaxation time is of interest in patients with acute myocarditis. T1 relaxation times will be directly obtained from the T1 maps through ROI analysis. T1 maps will be analyzed using a segmental approach. T1 relaxation times are given in [ms].
Myocardial T2 relaxation time
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Changes in myocardial T2 relaxation time is of interest in patients with acute myocarditis. T2 relaxation times will be directly obtained from T2 maps through ROI analysis. T2 maps will be analyzed using a segmental approach. T2 relaxation times are given in [ms].
Myocardial ECV measurements
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Changes in myocardial ECV parameters is of interest in patients with acute myocarditis. Hematocrit corrected ECV will be calculated using pre- and post-contrast T1 values for myocardium and blood pool using following formula: ECV= (1⁄T1 "myocardium post contrast"-1⁄T1 "myocadium pre contrast")/(1⁄T1 "blood post contrast"-1⁄ T1 "blood pre contrast") x (1-hematocrit). ECV is given in percentage.
Myocardial strain analysis (focussed on longitudinal strain)
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Changes in longitudinal strain as determined by echocardiography has been described in patient with acute myocarditis. In our study longitudinal strain is measured using feature tracking, which allows for strain calculation from standard MR cine datasets.
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 11 Dec 2015.
- Background: PubMed 24910904Luetkens JA, Doerner J, Thomas DK, Dabir D, Gieseke J, Sprinkart AM, Fimmers R, Stehning C, Homsi R, Schwab JO, Schild H, Naehle CP. Acute myocarditis: multiparametric cardiac MR imaging. Radiology. 2014 Nov;273(2):383-92. doi: 10.1148/radiol.14132540. Epub 2014 Jun 6.
- Derived from this study: PubMed 26476398Luetkens JA, Homsi R, Sprinkart AM, Doerner J, Dabir D, Kuetting DL, Block W, Andrie R, Stehning C, Fimmers R, Gieseke J, Thomas DK, Schild HH, Naehle CP. Incremental value of quantitative CMR including parametric mapping for the diagnosis of acute myocarditis. Eur Heart J Cardiovasc Imaging. 2016 Feb;17(2):154-61. doi: 10.1093/ehjci/jev246. Epub 2015 Oct 16.
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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 Myocarditis, run by University Hospital, Bonn at 1 site in Germany.
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 2 inclusion and 1 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 11 Dec 2015. 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 Germany. 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?
Myocardial T1 relaxation time (time frame: Measurement will be performed within 2 weeks after MRI scan.). The study lists 4 primary outcomes in all. 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 NCT02299856, which also lists 2 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 11 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.