2019-nCoV Outbreak and Cardiovascular Diseases | NCT04255940

Studies
2019-nCoV Outbreak and Cardiovascular Diseases

NCT04255940

Sponsor

Qilu Hospital of Shandong University

Status

Unknown status

Last Update Posted

Feb 5, 2020Actual

Enrollment

12,000Estimated

Phase

Not provided

Conditions

Cardiovascular Death; Major Adverse Cardiovascular Events

Interventions

Not provided

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2020Actual

Primary Completion Date

Apr 30, 2020Estimated

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Feb 3, 2020

First Submission Date that Met QC Criteria

Feb 3, 2020

First Posted Date

Feb 5, 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

Feb 3, 2020

Last Update Posted Date

Feb 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pan-Pan Hao, Dr., Qilu Hospital of Shandong UniversityPrincipal Investigator

Lead Sponsor

Qilu Hospital of Shandong UniversityOTHER

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

Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.

Detailed Description

This survey aims to assess whether the public anxiety from a novel coronavirus (2019-nCoV) outbreak increases cardiovascular disease risk in China. Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.

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

12,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular Death		3 months

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiovascular Events		3 months
Times From symptom onset to hospital arrival		3 months
Anxiety

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients visiting emergency department.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients visiting emergency department.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Panpan Hao, MD	Contact	86-18560086593		panda.how@sdu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Binzhou Medical Universty	Recruiting	Binzhou	Shandong		China

Label	Type	Description	Intervention Names
After outbreak
Past 3 months
Last year