NCT04104269

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35,621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

9 years

First QC Date

September 24, 2019

Last Update Submit

November 25, 2019

Conditions

Acute Myocardial Infarction

Keywords

Heart ruptureAcute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Heart rupture

    Includee free wall ventricular rupture and ventricular septal rupture

    Mortality 30 days

Study Arms (2)

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

Heart ruptureDIAGNOSTIC_TEST

Free wall rupture and Ventricular septal rupture

Mechanical Complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \. Non-cardiovascular comorbidity for AMI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Heart Rupture

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Yan Wang, PhD

    Xiamen Cardiovascular Hospital, Xiamen University

    STUDY CHAIR

Central Study Contacts

Yan Wang, PhD

CONTACT

8613860488088wy@medmail.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph D, FACC

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

January 1, 2011

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)