Mechanical Structure Complications After Acute Myocardial... | NCT04104269

Studies
Mechanical Structure Complications After Acute Myocardial Infarction

NCT04104269

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Status

Unknown status

Last Update Posted

Nov 26, 2019Actual

Enrollment

35,621Estimated

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

Nov 2019

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, 2019Estimated

Completion Date

Jan 31, 2020Estimated

First Submitted Date

Sep 24, 2019

First Submission Date that Met QC Criteria

Sep 24, 2019

First Posted Date

Sep 26, 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

Nov 25, 2019

Last Update Posted Date

Nov 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yan Wang, Ph D, FACC, 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

To determine the incidence and factors associated with heart rupture (HR) in acute myocardial infarction patients.

Detailed Description

We compared characteristics and angiographic patterns of heart rupture and without heart rupture patients enrolled in the trial.

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

35,621Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mechanical Complications		Include free wall ventricular rupture and ventricular septal rupture	Diagnostic Test: Heart rupture
Non-Mechanical Complications		Mechanical complications were not included in patients with AMI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heart rupture	Diagnostic Test	Free wall rupture and Ventricular septal rupture	Mechanical Complications

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rupture	Includee free wall ventricular rupture and ventricular septal rupture	Mortality 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. 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

Overall Officials

Name	Affiliation	Role
Yan Wang, PhD	Xiamen 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

Condition Browse Module

MeSH Terms

ID	Term
D006341	Heart Rupture

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided