NCT05124223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

1.7 years

First QC Date

November 16, 2021

Last Update Submit

November 16, 2021

Conditions

Myocarditis Acute

Keywords

COVID-19COVID-19-Vaccine

Outcome Measures

Primary Outcomes (1)

  • Acute Myocarditis

    Number of patients with CMR diagnosis of suspected acute myocarditis

    January 2020 to August 2021

Secondary Outcomes (1)

  • Subsided Myocarditis

    January 2020 to August 2021

Study Arms (2)

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

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

Interventions

Cardiac MRIDIAGNOSTIC_TEST

Cardiac MRI was performed as clinically indicated to assess cardiac pathology.

Post-COVID-19Post-COVID-19-Vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Heart Center Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of cardiovascular MRI

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 17, 2021

Study Start

January 1, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)