NCT04455347

Brief Summary

To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID\_19 related disease in pediatric patients with cardiac involvement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 15, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

4.5 years

First QC Date

July 1, 2020

Last Update Submit

April 11, 2023

Conditions

Keywords

COVID-19 InfectionChildrenAcute MyocarditisKawasaki-like-syndrome

Outcome Measures

Primary Outcomes (2)

  • Imaging data at Baseline

    Description of imaging data from MRI ans CT scan and associated clinical data.

    Baseline

  • Imagine data at Follow-up

    Description of imaging data from MRI ans CT scan and associated clinical data.

    During the 2 years follow-up period

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with a probable or a proven diagnosis of COVID 19 admitted for systemic acute inflammation and cardiac symptoms (cardiogenic shock or chest pain or clinical suspicion of acute myocarditis or left ventricular ejection fraction)

You may qualify if:

  • Patient with cardiac MRI or cardiac CT scan or thoracic CT scan admitted for acute inflammatory syndrome and cardiac compromise
  • Patient with PCR or antibodies test for COVID 19 (positive of negative)
  • Patient or parents of minor patients informed about collection of personal data for the study

You may not qualify if:

  • Patient or parents refusing personal data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker

Paris, 75015, France

RECRUITING

Related Publications (1)

  • Aeschlimann FA, Misra N, Hussein T, Panaioli E, Soslow JH, Crum K, Steele JM, Huber S, Marcora S, Brambilla P, Jain S, Navallas M, Giuli V, Rucker B, Angst F, Patel MD, Azarine A, Caro-Dominguez P, Cavaliere A, Di Salvo G, Ferroni F, Agnoletti G, Bonnemains L, Martins D, Boddaert N, Wong J, Pushparajah K, Raimondi F. Myocardial involvement in children with post-COVID multisystem inflammatory syndrome: a cardiovascular magnetic resonance based multicenter international study-the CARDOVID registry. J Cardiovasc Magn Reson. 2021 Dec 30;23(1):140. doi: 10.1186/s12968-021-00841-1.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Francesca Raimondi, MD

    Hôpital Necker

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 2, 2020

Study Start

June 15, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations