The Evaluation and Management of Patients With Acute Ches... | NCT02384863

Studies
The Evaluation and Management of Patients With Acute Chest Pain in China

NCT02384863

Sponsor

Yuguo Chen

Status

Unknown status

Last Update Posted

Mar 10, 2015Estimated

Enrollment

18,000Estimated

Phase

Not provided

Conditions

Chest Pain
Acute Coronary Syndrome

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

ID	Type	Description	Link
ChiCTR-IOQ-14005268	Registry Identifier	Chinese Clinical Trial Registry

Status Module

Record Verification Date

Mar 2015

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

Oct 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 26, 2015

First Submission Date that Met QC Criteria

Mar 9, 2015

First Posted Date

Mar 10, 2015Estimated

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 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuguo Chen, President-elect, Chinese Society of Emergency Medicine;Director, Chest Pain Center, Qilu Hospital of Shandong University, Qilu Hospital of Shandong UniversitySponsor-Investigator

Lead Sponsor

Yuguo ChenOTHER

Collaborators

Name	Class
National Health and Family Planning Commission, P.R.China	OTHER_GOV
West China Hospital	OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to describe the characteristics, evaluation, management and outcomes of acute chest pain, and to provide opportunities for future initiatives to improve the emergency care for patients experiencing acute chest pain in China.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
in-hospital mortality		During hospital stay,an expected average of 7 days

Secondary Outcomes

Measure	Description	Time Frame
Time between symptom onset and hospital admission		Time interval from symptom onset to arrival at the Emergency Department，an expected median of 9 hours
Major adverse cardiac events (MACE)	Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute chest pain(pain in the area inferior to the clavicle, superior to the rib arch, and anterior to the bilateral posterior axillary line）;
Possible Acute Coronary Syndrome;
Symptoms occurring within last 24 hours;
Informed consent from patient or next of kin.

Exclusion Criteria:

Arrhythmia or heart failure not cause by myocardial ischemia;
Confirmed lung disease without chest pain;
No onset of symptoms within last 24 hours;
No written consensus.

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

consecutive patients attending the emergency department in 7 Chinese grade Ⅲ hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuguo Chen, M.D., Ph.D.	Contact	86-18678812777		chen919085@126.com

Overall Officials

Name	Affiliation	Role
Yuguo Chen, M.D., Ph.D.	Qilu Hospital of Shandong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Harbin Medical University	Not yet recruiting	Harbin	Heilongjiang	150001	China

Condition Browse Module

MeSH Terms

ID	Term
D002637	Chest Pain
D054058	Acute Coronary Syndrome
D004630	Emergencies

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