Multicentre REtrospective StuDy of Treatment and OUtComes... | NCT03763968

Studies
Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province

NCT03763968

Sponsor

Yan-song Guo

Status

Completed

Last Update Posted

Jan 3, 2019Actual

Enrollment

7,000Actual

Phase

Not provided

Conditions

ST-segment Elevation Myocardial Infarction

Interventions

treatment and outcome

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

Jan 2019

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

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Nov 30, 2018

First Submission Date that Met QC Criteria

Dec 3, 2018

First Posted Date

Dec 4, 2018Actual

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

Jan 1, 2019

Last Update Posted Date

Jan 3, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yan-song Guo, Fujian Provincial Hospital, Fujian Provincial HospitalSponsor-Investigator

Lead Sponsor

Yan-song GuoOTHER

Collaborators

Name	Class
Longyan City First Hospital	OTHER
The Affiliated Hospital of Putian University	OTHER
The Second Affiliated Hospital of Fujian Medical University	OTHER

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

This is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were conducted at five regional representative hospitals in Fujian province, which included the Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital of Ningde City.

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

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

7,000Actual

Name	Type	Description	Arm Group Labels	Other Names
treatment and outcome	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital mortality	all mortality,cardiovascular mortality	5years

Secondary Outcomes

Measure	Description	Time Frame
other in-hospital complications	recurrent myocardial infarction, target vessel revascularization,contrast-induced acute kidney injury,stroke,bleeding,and so on	5years
MACEs for long-term follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

STEMI patients with symptom onset within 30 days

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

STEMI patients with symptom onset within 30 days

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kai-yang Lin, Doctor	Fujian Provincial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Provincial		Fuzhou	Fujian	350001	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
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016896	Treatment Outcome

Ancestor Terms

ID	Term
D011379	Prognosis
D003933	Diagnosis
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care

Browse Leaves

Not provided

Browse Branches

Not provided