NCT04312464

Brief Summary

This study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in COVID-19 patients. There is no additional examination and treatment for this project.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 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

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 4, 2020

Last Update Submit

March 13, 2020

Conditions

COVID-19Cardiovascular Diseases

Keywords

COVID-19myocardial injury

Outcome Measures

Primary Outcomes (2)

  • The myocardial injury incidence

    The myocardial injury incidence of COVID-19 patients

    75 days

  • The risk factors analysis for the death

    The risk factors analysis for the death of COVID-19 patients

    75 days

Secondary Outcomes (4)

  • Clinical characteristics

    75 days

  • Clinical course

    75 days

  • Cardiovascular comorbidity

    75 days

  • Analysis of causes of death

    75 days

Study Arms (2)

Discharged group

The individual which is defined as patient discharged from hospital

Other: non

Dead group

The individual which is defined as patient with all-cause death

Other: non

Interventions

nonOTHER

no intervention

Dead groupDischarged group

Eligibility Criteria

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

The laboratory-confirmed patients with confirmed COVID-19 admitted to headquarters, west campus and cancer center of Union Hospital, Tongji Medical College, Huazhong University of science and technology, from January 1st to March 15th, 2020

You may qualify if:

  • (1) Age ≥18 years. (2) Laboratory (RT-PCR) confirmed infection with SARS-CoV-2. (3) Lung involvement confirmed with chest imaging.

You may not qualify if:

  • No cTnI test on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

COVID-19Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 18, 2020

Study Start

January 1, 2020

Primary Completion

March 15, 2020

Study Completion

March 18, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations

CN(1)