MyocarditisMyoRacerNCT02177630
Magnetic Resonance Imaging in Myocarditis
An observational study of Myocarditis, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocarditis
- What is being tested?
- Endomyocardial Biopsy
- How many people
- 129 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical suspicion of myocarditis
Who may be able to join
- Symptoms such as:
- Dyspnea or Orthopnea or
- Palpitations or
- Exercise intolerance or
- Angina
- Evidence of myocardial involvement:
Show all 9Show fewer
- ventricular dysfunction on echocardiography or
- new or persistent ECG changes
- elevated Troponin T History of viral infection
Who cannot join
- Contraindication for magnetic resonance imaging
- Impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2
- Patients presenting with pregnancy
- Patients without informed consent
- Participation in another trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocarditis and the Role of Advanced Magnetic Resonance Imaging
The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners
Read the detailed description
In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at 1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1 and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated.
The protocol also includes a follow-up MR can at 3 months.
- Conditions
- Myocarditis
- Being tested
- Endomyocardial Biopsy
- Keywords
- myocarditis, myocardial inflammation, imaging, magnetic resonance
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomyocardial BiopsyOther
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging and endomyocardial biopsy | Magnetic resonance imaging and endomyocardial biopsy Receives: Other: Endomyocardial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
The diagnostic accuracy of individual and a combination of MR imaging sequences (late enhancement images, assessment of global edema, relative enhancement and T1 and T2 mapping sequences) will be determined by comparison to endomyocardial biopsies, which serve as diagnostic gold-standard
Measured: baseline
Secondary outcomes (1)
Diagnostic performance of biventricular endomyocardial biopsies
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2015
- Study completionDec 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
- Investigators
- Philipp Lurz, MD, PhD, Principal investigator, Heart Center of the University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177630
- Sponsor's protocol ID
- 123456123456
- Acronym
- MyoRacer
- Status last verified
- May 2021
- First submitted
- 22 Jun 2014
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Baessler B, Luecke C, Lurz J, Klingel K, Das A, von Roeder M, de Waha-Thiele S, Besler C, Rommel KP, Maintz D, Gutberlet M, Thiele H, Lurz P. Cardiac MRI and Texture Analysis of Myocardial T1 and T2 Maps in Myocarditis with Acute versus Chronic Symptoms of Heart Failure. Radiology. 2019 Sep;292(3):608-617. doi: 10.1148/radiol.2019190101. Epub 2019 Jul 30.
PubMed 31361205Lurz P, Luecke C, Eitel I, Fohrenbach F, Frank C, Grothoff M, de Waha S, Rommel KP, Lurz JA, Klingel K, Kandolf R, Schuler G, Thiele H, Gutberlet M. Comprehensive Cardiac Magnetic Resonance Imaging in Patients With Suspected Myocarditis: The MyoRacer-Trial. J Am Coll Cardiol. 2016 Apr 19;67(15):1800-1811. doi: 10.1016/j.jacc.2016.02.013.
PubMed 27081020
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocarditis and the Role of Advanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02177630
- Acronym / sponsor ID
- MyoRacer / 123456123456
- Conditions
- Myocarditis
- Keywords
- myocarditis, myocardial inflammation, imaging, magnetic resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jun 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.
The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners
Detailed description
In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at 1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1 and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated.
The protocol also includes a follow-up MR can at 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging and endomyocardial biopsy | – | Other: Endomyocardial BiopsyMagnetic resonance imaging and endomyocardial biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical suspicion of myocarditis
Key inclusion criteria (9 listed)
- Dyspnea or Orthopnea or
- Palpitations or
- Exercise intolerance or
- Angina
- ventricular dysfunction on echocardiography or
Key exclusion criteria (5 listed)
- Contraindication for magnetic resonance imaging
- Impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2
- Patients presenting with pregnancy
- Patients without informed consent
- Participation in another trial.
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 |
|---|---|---|
| Endomyocardial Biopsy | Other | Magnetic resonance imaging and endomyocardial biopsy |
Primary outcome
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences
Time frame: baseline
The diagnostic accuracy of individual and a combination of MR imaging sequences (late enhancement images, assessment of global edema, relative enhancement and T1 and T2 mapping sequences) will be determined by comparison to endomyocardial biopsies, which serve as diagnostic gold-standard
1 secondary outcome
Diagnostic performance of biventricular endomyocardial biopsies
Time frame: baseline
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 10 May 2021.
- Derived from this study: PubMed 31361205Baessler B, Luecke C, Lurz J, Klingel K, Das A, von Roeder M, de Waha-Thiele S, Besler C, Rommel KP, Maintz D, Gutberlet M, Thiele H, Lurz P. Cardiac MRI and Texture Analysis of Myocardial T1 and T2 Maps in Myocarditis with Acute versus Chronic Symptoms of Heart Failure. Radiology. 2019 Sep;292(3):608-617. doi: 10.1148/radiol.2019190101. Epub 2019 Jul 30.
- Derived from this study: PubMed 27081020Lurz P, Luecke C, Eitel I, Fohrenbach F, Frank C, Grothoff M, de Waha S, Rommel KP, Lurz JA, Klingel K, Kandolf R, Schuler G, Thiele H, Gutberlet M. Comprehensive Cardiac Magnetic Resonance Imaging in Patients With Suspected Myocarditis: The MyoRacer-Trial. J Am Coll Cardiol. 2016 Apr 19;67(15):1800-1811. doi: 10.1016/j.jacc.2016.02.013.
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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.
Philipp Lurz, MD, PhD principal investigator
Heart Center of the University of Leipzig
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 Heart Center Leipzig - University Hospital 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 9 inclusion and 5 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 10 May 2021. 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?
Accuracy, sensitivity and specificity of magnetic resonance imaging sequences (time frame: baseline). 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 NCT02177630, 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 10 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.