Scoring Model for Predicting Outcome in Patients With Car... | NCT04850248

Studies
Scoring Model for Predicting Outcome in Patients With Cardiogenic Shock

NCT04850248

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Apr 20, 2021Actual

Enrollment

999Estimated

Phase

Not provided

Conditions

Cardiogenic Shock

Interventions

no intervention, this is an observational study

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Apr 14, 2021

First Submission Date that Met QC Criteria

Apr 18, 2021

First Posted Date

Apr 20, 2021Actual

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

Apr 18, 2021

Last Update Posted Date

Apr 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 study aims to develop a predictive model for the outcomes of patients with cardiogenic shock

Detailed Description

This retrospective observational study will enroll patients with cardiogenic shock admitted to the cardiac care unit. Patient characteristics, clinical events during hospitalization, and laboratory examination findings will be collected and analyzed to determine factors associated with mortality. A nomogram will be developed accordingly and will undergo both internal and external validation.

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

999Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention, this is an observational study	Other	no intervention, this is an observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	In-hospital mortality	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cardiogenic shock
Admitted to the cardiac care unit (CCU)

Exclusion Criteria:

Non-cardiogenic shock in origin
Post open heart surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study will enroll patients with who arrived at the emergency department with cardiogenic shock and subsequently admitted to the cardiac care unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min-Shan Tsai, MD, PhD	Contact	02-23123456	65632	mshanmshan@gmail.com

Overall Officials

Name	Affiliation	Role
Min-Shan Tsai, MD, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Feb 21, 2024
Reset	Aug 2, 2024

Submission Tracking

Estimated Results First Submitted Date

Feb 21, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 21, 2024			Aug 2, 2024

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided