Analysis of Cardiac Damage Post Infection With SARS-CoV-2 and Post Vaccination Against COVID-19
NCT ID: NCT05124223
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
131 participants
OBSERVATIONAL
2020-01-01
2021-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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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.
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.
Cardiac MRI
Cardiac MRI was performed as clinically indicated to assess cardiac pathology.
Interventions
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Cardiac MRI
Cardiac MRI was performed as clinically indicated to assess cardiac pathology.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sebastian Kelle
OTHER
Responsible Party
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Sebastian Kelle
Head of cardiovascular MRI
Locations
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German Heart Center Berlin
Berlin, , Germany
Countries
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Other Identifiers
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EA2/020/21
Identifier Type: -
Identifier Source: org_study_id