Suspected Acute MyocarditisNCT01962584
CMR in Patients With Myocarditis
An observational study of Suspected Acute Myocarditis, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
To evaluate the additive values of T1 mapping in patients with acute myocarditis. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suspected Acute Myocarditis
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Oct 2014
- 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 with suspected acute myocarditis and otherwise unremarkable cardiac history exclusion of CAD in invasive coronary angiography
Who may be able to join
- patients with suspected acute myocarditis and otherwise unremarkable cardiac history
Who cannot join
- pregnancy
- contraindications for MR imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of CMR Including T1 Mapping in Patients With Acute Myocarditis
To evaluate the additive values of T1 mapping in patients with acute myocarditis.
Read the detailed description
Cardiac magnetic resonance (CMR) is an established non-invasive diagnostic tool for acute and chronic myocarditis. Established CMR criteria for diagnosing myocarditis are edema on black-blood T2-weighted imaging, relative contrast enhancement seen on T1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis.
Recently, tissue characterization based on calculation of myocardial T1 relaxation time (T1 mapping) as well as T1-derived extracellular volume fraction has become available. Recently, reference values for myocardial T1 relaxation times at 3T for healthy volunteers were published for CMR. However, to date no comprehensive data for multiparametric CMR in patients with suspected myocarditis at 3 Tesla is available. Therefore, the purpose of this prospective study was to evaluate the diagnostic value of CMR at 3T in patients with suspected acute myocarditis using a multiparametric CMR approach including T1 mapping as novel tool for tissue characterization.
CMR will be performed within 7 days after hospital admission for "suspected acute myocarditis".
- Conditions
- Suspected Acute Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SAM | patients with suspected acute myocarditis | |
| HC | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1 relaxation times
quantification of T1 relaxation times
Measured: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".
Secondary outcomes (1)
Extracellular volume (ECV)
calculation of extracellular volume based on T1 relaxation time
Measured: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Acute 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
- 66 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
- NCT01962584
- Sponsor's protocol ID
- 150/13
- Status last verified
- Dec 2015
- First submitted
- 4 Oct 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Value of CMR Including T1 Mapping in Patients With Acute Myocarditis
- ClinicalTrials.gov ID
- NCT01962584
- Acronym / sponsor ID
- 150/13
- Conditions
- Suspected Acute Myocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Oct 2013 (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.
To evaluate the additive values of T1 mapping in patients with acute myocarditis.
Detailed description
Cardiac magnetic resonance (CMR) is an established non-invasive diagnostic tool for acute and chronic myocarditis. Established CMR criteria for diagnosing myocarditis are edema on black-blood T2-weighted imaging, relative contrast enhancement seen on T1-weighted imaging for assessment of hyperemia, and late contrast-agent enhancement seen with inversion recovery late enhancement technique for visualization of myocardial fibrosis.
Recently, tissue characterization based on calculation of myocardial T1 relaxation time (T1 mapping) as well as T1-derived extracellular volume fraction has become available. Recently, reference values for myocardial T1 relaxation times at 3T for healthy volunteers were published for CMR. However, to date no comprehensive data for multiparametric CMR in patients with suspected myocarditis at 3 Tesla is available. Therefore, the purpose of this prospective study was to evaluate the diagnostic value of CMR at 3T in patients with suspected acute myocarditis using a multiparametric CMR approach including T1 mapping as novel tool for tissue characterization.
CMR will be performed within 7 days after hospital admission for "suspected acute myocarditis".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAM | – | –patients with suspected acute myocarditis |
| HC | – | –Healthy controls |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with suspected acute myocarditis and otherwise unremarkable cardiac history exclusion of CAD in invasive coronary angiography
Key inclusion criteria (1 listed)
- patients with suspected acute myocarditis and otherwise unremarkable cardiac history
Key exclusion criteria (2 listed)
- pregnancy
- contraindications for MR imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T1 relaxation times
Time frame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".
quantification of T1 relaxation times
1 secondary outcome
Extracellular volume (ECV)
Time frame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".
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.
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 Suspected Acute 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 1 inclusion and 2 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?
T1 relaxation times (time frame: time of CMR, CMR will be performed within 7 days after hospital admission for "suspected acute myocardtitis".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.