Rapid Diagnosis of Patients With Chest Pain During the Co... | NCT05394038

Studies
Rapid Diagnosis of Patients With Chest Pain During the Covid-19 Outbreak (My-ABCDE)

NCT05394038

Sponsor

Shanghai 10th People's Hospital

Status

Completed

Last Update Posted

May 27, 2022Actual

Enrollment

2,218Actual

Phase

Not provided

Conditions

Chest Pain

Interventions

None，observational study.

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

May 20, 2022Actual

Completion Date

May 20, 2022Actual

First Submitted Date

May 25, 2022

First Submission Date that Met QC Criteria

May 25, 2022

First Posted Date

May 27, 2022Actual

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

May 25, 2022

Last Update Posted Date

May 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ya-Wei Xu, Director, Director of Cardiovascular Medicine, Shanghai 10th People's HospitalPrincipal Investigator

Lead Sponsor

Shanghai 10th People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Detailed Description

During the outbreak of COVID-19, among patients with chest tightness and chest pain as the main symptoms in major medical institutions in Shanghai, China, the past medical history and rapid testing were used to quickly identify the risk stratification of the patients. Past medical history collection includes diabetes, hypertension, coronary atherosclerotic heart disease, percutaneous coronary stent implantation, etc. Rapid detection includes rapid myocardial markers, coagulation function, electrocardiogram, chest CT, etc. Risk stratification in the shortest possible time to reduce the time patients spend congregating in hospitals and reduce unnecessary contact to reduce the risk of Covid-19 infection.

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

2,218Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPC Cohort		A patient with chest tightness and pain during the Covid-19 outbreak.	Other: None，observational study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None，observational study.	Other	observational study	CPC Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis time	The time from the first medical contact to the time of diagnosis.	1 week

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	Preliminary and confirmed diagnoses were the same proportion of the total number of patients.	1week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who came to the hospital with chest tightness and chest pain during Covid-19.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients who came to the hospital with chest tightness and chest pain during Covid-19.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yawei Xu, PhD	Tongji University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Tenth People's Hospital		Shanghai	Shanghai Municipality	200072	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002637	Chest Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided