Myocarditis AcuteNCT05124223
Analysis of Cardiac Damage Post Infection With SARS-CoV-2 and Post Vaccination Against COVID-19
An observational study of Myocarditis Acute, run by Sebastian Kelle at 1 site in Germany.
Trial summary
From May 2020 to May 2021, the investigators retrospectively evaluated clinical cardiac magnetic resonance (CMR) examinations performed in patients with suspected cardiac involvement post COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Acute
- What is being tested?
- Cardiac MRI
- Type of treatment
- Vaccines
- How many people
- 131 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Aug 2021
- 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: Clinical all-comers with suspected cardiac Involvement after COVID-19 or COVID-19-vaccination
Who may be able to join
- Cardiac MRI for suspected cardiac Involvement after COVID-19 or COVID-19-vaccination
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
From May 2020 to May 2021, the investigators retrospectively evaluated clinical cardiac magnetic resonance (CMR) examinations performed in patients with suspected cardiac involvement post COVID-19. Between May 2021 and August 2021, the investigators evaluated patients with suspected cardiac disease after COVID-19 vaccination.
Read the detailed description
Hospital database for patients that underwent a clinical CMR examination between May 2020 and May 2021 for suspected cardiac pathology post COVID-19 were analyzed. For comparison, CMR examinations from January until August 2021 were searched for suspected cardiac pathology post COVID-19 vaccination. The study complies with the declaration of Helsinki and was approved by the ethics committee of the Charité-Universitätsmedizin Berlin (EA2/020/21).
CMR Imaging All scans were performed for clinical indications on either a Philips Ingenia 3.0 T scanner or a Philips Ambition 1.5 T scanner according to recent recommendations for CMR in patients post COVID-19. Protocols were adjusted to the clinical scenario but generally included standard CINE imaging, T2 STIR edema imaging, basal and medial short axis T2 mapping (T2-GraSE) and pre- and post-contrast T1 mapping (MOLLI), and Late-Enhancement-Imaging (mDIXON). Vasodilator stress with Regadenosone or Adenosine was performed in patients with clinically suspected myocardial ischemia. The Adenosine dose was 0.140 µg/kg/min, with an increase to 0.210 µg/kg/min in case of insufficient response. The Regadenosone dose was 200µg irrespective of weight, followed by Theophyllin reversal as needed (max. 200mg). The contrast agent was 0.1 mmol/kg Gadobutrol (Gadovist®, Bayer AG, Leverkusen, Germany).
CMR image analysis Image post-processing and measurements were performed according to recent recommendations using dedicated CMR post-processing software (IntelliSpace Portal V11.1, Philips, Best, The Netherlands). The diagnosis of 'probable myocarditis' was based on the updated Lake Louise Criteria requiring findings of myocardial damage (LGE) and edema (T2 STIR or T2 mapping) in a non-ischemic pattern (intramyocardial or subepicardial). Evidence of edema without myocardial damage was considered 'possible myocarditis' whereas myocardial damage without edema was considered 'subsided myocarditis.
- Conditions
- Myocarditis Acute
- Being tested
- Cardiac MRI
- Keywords
- COVID-19, COVID-19-Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Cardiac MRI was performed as clinically indicated to assess cardiac pathology.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID-19 | From May 2020 to May 2021, we retrospectively examined 104 clinical cardiac magnetic resonance (CMR) examinations performed in patients with suspected cardiac involvement post COVID-19. The mean time from first positive PCR to CMR was 112 +- 76 days. During their COVID-19 disease, 21% of patients required hospitalization, 17% supplemental oxygen and 7% mechanical ventilation. Receives: Diagnostic Test: Cardiac MRI | |
| Post-COVID-19-Vaccination | Between May 2021 and August 2021, we examined 27 patients with suspected cardiac disease after COVID-19 vaccination. Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Myocarditis
Number of patients with CMR diagnosis of suspected acute myocarditis
Measured: January 2020 to August 2021
Secondary outcomes (1)
Subsided Myocarditis
Number of patients with CMR diagnosis of suspected subsided myocarditis
Measured: January 2020 to August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Jan 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sebastian Kelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sebastian Kelle, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124223
- Sponsor's protocol ID
- EA2/020/21
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cardiac Damage Post Infection With SARS-CoV-2 and Post Vaccination Against COVID-19
- ClinicalTrials.gov ID
- NCT05124223
- Acronym / sponsor ID
- EA2/020/21
- Conditions
- Myocarditis Acute
- Keywords
- COVID-19, COVID-19-Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Sebastian KelleUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 17 Nov 2021 (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.
From May 2020 to May 2021, the investigators retrospectively evaluated clinical cardiac magnetic resonance (CMR) examinations performed in patients with suspected cardiac involvement post COVID-19. Between May 2021 and August 2021, the investigators evaluated patients with suspected cardiac disease after COVID-19 vaccination.
Detailed description
Hospital database for patients that underwent a clinical CMR examination between May 2020 and May 2021 for suspected cardiac pathology post COVID-19 were analyzed. For comparison, CMR examinations from January until August 2021 were searched for suspected cardiac pathology post COVID-19 vaccination. The study complies with the declaration of Helsinki and was approved by the ethics committee of the Charité-Universitätsmedizin Berlin (EA2/020/21).
CMR Imaging All scans were performed for clinical indications on either a Philips Ingenia 3.0 T scanner or a Philips Ambition 1.5 T scanner according to recent recommendations for CMR in patients post COVID-19. Protocols were adjusted to the clinical scenario but generally included standard CINE imaging, T2 STIR edema imaging, basal and medial short axis T2 mapping (T2-GraSE) and pre- and post-contrast T1 mapping (MOLLI), and Late-Enhancement-Imaging (mDIXON). Vasodilator stress with Regadenosone or Adenosine was performed in patients with clinically suspected myocardial ischemia. The Adenosine dose was 0.140 µg/kg/min, with an increase to 0.210 µg/kg/min in case of insufficient response. The Regadenosone dose was 200µg irrespective of weight, followed by Theophyllin reversal as needed (max. 200mg). The contrast agent was 0.1 mmol/kg Gadobutrol (Gadovist®, Bayer AG, Leverkusen, Germany).
CMR image analysis Image post-processing and measurements were performed according to recent recommendations using dedicated CMR post-processing software (IntelliSpace Portal V11.1, Philips, Best, The Netherlands). The diagnosis of 'probable myocarditis' was based on the updated Lake Louise Criteria requiring findings of myocardial damage (LGE) and edema (T2 STIR or T2 mapping) in a non-ischemic pattern (intramyocardial or subepicardial). Evidence of edema without myocardial damage was considered 'possible myocarditis' whereas myocardial damage without edema was considered 'subsided myocarditis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID-19 | – | Diagnostic Test: Cardiac MRIFrom May 2020 to May 2021, we retrospectively examined 104 clinical cardiac magnetic resonance (CMR) examinations performed in patients with suspected cardiac involvement post COVID-19. The mean time from first positive PCR to CMR was 112 +- 76 days. During their COVID-19 disease, 21% of patients required hospitalization, 17% supplemental oxygen and 7% mechanical ventilation. |
| Post-COVID-19-Vaccination | – | Diagnostic Test: Cardiac MRIBetween May 2021 and August 2021, we examined 27 patients with suspected cardiac disease after COVID-19 vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical all-comers with suspected cardiac Involvement after COVID-19 or COVID-19-vaccination
Key inclusion criteria (1 listed)
- Cardiac MRI for suspected cardiac Involvement after COVID-19 or COVID-19-vaccination
Key exclusion criteria (1 listed)
- None
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 MRICardiac MRI was performed as clinically indicated to assess cardiac pathology. | Diagnostic test | Post-COVID-19, Post-COVID-19-Vaccination |
Primary outcome
Acute Myocarditis
Time frame: January 2020 to August 2021
Number of patients with CMR diagnosis of suspected acute myocarditis
1 secondary outcome
Subsided Myocarditis
Time frame: January 2020 to August 2021
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 24 Nov 2021.
- Individual participant dataSharing planned: No
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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 Acute, run by Sebastian Kelle 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 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 24 Nov 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?
Acute Myocarditis (time frame: January 2020 to August 2021). 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 24 Nov 2021.