Left Ventricular Free-wall Ruptrue After Acute Myocardial... | NCT04172168

Studies
Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction (LVFR-AMI)

NCT04172168

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Status

Unknown status

Last Update Posted

Apr 1, 2021Actual

Enrollment

17,568Estimated

Phase

Not provided

Conditions

Acute Myocardial Infarction

Interventions

Heart rupture

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

Mar 2021

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 1, 2011Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Mar 31, 2021Estimated

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 18, 2019

First Posted Date

Nov 21, 2019Actual

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 31, 2021

Last Update Posted Date

Apr 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yan Wang, President, Xiamen Cardiovascular Hospital, Xiamen UniversityPrincipal Investigator

Lead Sponsor

Xiamen Cardiovascular Hospital, Xiamen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality.

Detailed Description

The actual mortality of LVFR is close to 100%. Despite the mortality rate for LVFR has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. The coronary anatomy distribution associated with LVFR has an interesting phenomenon. From the perspective of different coronary distribution, we can better known the risk factors related to LVFR.

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

17,568Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart rupture		Include left ventricular free-wall ruptrue after AMI	Diagnostic Test: Heart rupture
Non heart rupture		AMI with non heart rupture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heart rupture	Diagnostic Test	Left ventricular free-wall ruptrue after AMI	Heart rupture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of heart ruputre	Left Ventricular Free-wall Ruptrue	Mortality 30 days

Secondary Outcomes

Measure	Description	Time Frame
Rate of cardiogenic shock	Cardiogenic shock After AMI	Hospitalization 30 days
Rate of cardiac arrest	Cardiac arrest After AMI	Hospitalization 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

Non-cardiovascular comorbidity for AMI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population of acute myocardial infarction (STEMI or NSTEMI) patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan Wang, PhD	Contact	+8613860488088		wy@medmail.com.cn
Bin Wang, PhD	Contact	+8613400664305		mocw361@163.com

Overall Officials

Name	Affiliation	Role
Yan Wang, PhD	Cardiovascular Hospital, Xiamen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiamen Cardiovascular Hospital Xiamen University	Recruiting	Xiamen	Fujian	361000	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