Analysis of Cardiac Damage Post Infection With SARS-CoV-2 and Post Vaccination Against COVID-19

Myocarditis Acute Clinical Trial

Official title:

Analysis of Cardiac Damage Post Infection With SARS-CoV-2 and Post Vaccination Against COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124223
• Other study ID #: EA2/020/21
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: German Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Between May 2021 and August 2021, the investigators evaluated patients with suspected cardiac disease after COVID-19 vaccination.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac MRI for suspected cardiac Involvement after COVID-19 or COVID-19-vaccination

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID-19
• Myocarditis
• Myocarditis Acute

Intervention

Diagnostic Test:
• Cardiac MRI
Cardiac MRI was performed as clinically indicated to assess cardiac pathology.

Locations

Country	Name	City	State
Germany	German Heart Center Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sebastian Kelle

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Myocarditis	Number of patients with CMR diagnosis of suspected acute myocarditis	January 2020 to August 2021
Secondary	Subsided Myocarditis	Number of patients with CMR diagnosis of suspected subsided myocarditis	January 2020 to August 2021