Acute Myocardial Infarction Study in Northeastern China | NCT04451967

Studies
Acute Myocardial Infarction Study in Northeastern China

NCT04451967

Sponsor

Second Hospital of Jilin University

Status

Unknown status

Last Update Posted

Jun 30, 2020Actual

Enrollment

3,159Estimated

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

thrombolysis

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

Jun 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

Sep 9, 2019Actual

Primary Completion Date

Sep 9, 2020Estimated

Completion Date

Sep 9, 2022Estimated

First Submitted Date

Jun 26, 2020

First Submission Date that Met QC Criteria

Jun 29, 2020

First Posted Date

Jun 30, 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

Jun 29, 2020

Last Update Posted Date

Jun 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Second Hospital of Jilin UniversityOTHER

Collaborators

Name	Class
Yanbian University Hospital	UNKNOWN
Dunhua City Hospital in Jilin Province	UNKNOWN
Liaoyuan City Central Hospital	UNKNOWN
Dongliao People's Hospital

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 real-world prospective cohort study aiming to generate knowledge about the characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).

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

3,159Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transfer after thrombolysis			Procedure: thrombolysis
Transfer after DAPT
Direct transfer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thrombolysis	Procedure	transfer after thrombolysis for STEMI patients within 6h since onset	Transfer after thrombolysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause death	all-cause death	2 years post discharge

Secondary Outcomes

Measure	Description	Time Frame
major adverse cardiac events (MACE)	recurrent angina, non-fatal myocardial infarction, cardiac failure, malignant arrhythmia, and death from cardiovascular causes	2 years post discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, meet Fourth Universal Definition for Myocardial Infarction (2018)

Exclusion Criteria:

Types 4a and type 5 AMI

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

Eligible patients must be admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, including ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Final inclusion criteria must meet Fourth Universal Definition for Myocardial Infarction (2018)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tianyi Li, Ph.D	Contact	+8615843024731		litianyi@jlu.edu.cn

Overall Officials

Name	Affiliation	Role
Bin Liu, Ph.D	Second Hospital of Jilin University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The second hospital of Jilin university	Recruiting	Changchun	Jilin	130041	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34035090	Derived	Li T, Wu J, Liu J, Sun W, Qi C, Liu B, Wells GA, Wang J; Acute Myocardial Infarction Study in Northeastern China (AMINoC). Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study. BMJ Open. 2021 May 25;11(5):e042936. doi: 10.1136/bmjopen-2020-042936.

ID	Term
D050299	Fibrin Modulating Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses