Myocardial Damage in COVID-19 | NCT04312464

Studies
Myocardial Damage in COVID-19

NCT04312464

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 18, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

COVID-19
Cardiovascular Diseases

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Mar 15, 2020Estimated

Completion Date

Mar 18, 2020Estimated

First Submitted Date

Mar 4, 2020

First Submission Date that Met QC Criteria

Mar 13, 2020

First Posted Date

Mar 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2020

Last Update Posted Date

Mar 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiang Cheng, Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The epidemic of the COVID-19 has expanded from Wuhan through out China, and is being exported to a growing number of countries. Recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with COVID-19, and this proportion in patients admitted to the ICU (22.2%) is higher than patients not treated in the ICU (2.0%). Thus, cardiac troponin I (cTNI), the biomarker of cardiac injury, might be a clinical predictor of COVID-19 patient outcomes. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
non	Other	no intervention	Dead group Discharged group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Clinical characteristics	The clinical characteristics description of COVID-19 patients	75 days
Clinical course	The clinical course description of COVID-19 patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No cTnI test on admission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430022	China

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided