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

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.

Study Overview

• Status: Completed
• Conditions: Myocarditis Acute
• Intervention / Treatment: Diagnostic test: Cardiac MRI

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 Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • German Heart Center Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical all-comers with suspected cardiac Involvement after COVID-19 or COVID-19-vaccination

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Cardiac MRI; Cardiac MRI was performed as clinically indicated to assess cardiac pathology.
Post-COVID-19-Vaccination; Between May 2021 and August 2021, we examined 27 patients with suspected cardiac disease after COVID-19 vaccination.	Diagnostic test: Cardiac MRI; Cardiac MRI was performed as clinically indicated to assess cardiac pathology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Myocarditis	Number of patients with CMR diagnosis of suspected acute myocarditis	January 2020 to August 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subsided Myocarditis	Number of patients with CMR diagnosis of suspected subsided myocarditis	January 2020 to August 2021

Collaborators and Investigators

• Sponsor: Sebastian Kelle

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; COVID-19-Vaccine
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Cardiomyopathies; COVID-19; Myocarditis
• Other Study ID Numbers: EA2/020/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No