Outcome of Patients Treated With IABP | NCT04405856

Studies
Outcome of Patients Treated With IABP

NCT04405856

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

May 28, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome
Cardiogenic Shock
Coronary Artery Disease
Heart Failure
Left Ventricular Dysfunction
Low Cardiac Output Syndrome
Post-cardiac Surgery

Interventions

Intra Aortic Balloon Pump

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

May 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

Feb 1, 2012Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 26, 2020

First Posted Date

May 28, 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

May 26, 2020

Last Update Posted Date

May 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong Liu, Investigator of Department of Cardiac Surgery, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing Medical 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

Intra-Aortic Balloon Pumps (IABP) is a widely used and effective left ventricular adjuvant therapy. IABP is an inflatable device placed in the aorta that inflates with diastole and deflates with systole. The aim of this study is to investigate the outcome of patients treated With IABP, and to evaluate the short-term and long-term outcomes of patients with IABP.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intra Aortic Balloon Pump	Device	Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality		30 days after IABP implantation

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality		3 months after IABP implantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving IABP for circulatory support

Exclusion Criteria:

Refusal of consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients receiving IABP for circulatory support

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hong Liu, MD	Contact	18801281613		DR.HONGLIU@FOXMAIL.COM
Yong-feng Shao, MD	Contact	02568303100		yfshaojph@sina.com

Overall Officials

Name	Affiliation	Role
Yong-feng Shao, MD	The First Affiliated Hospital with Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of nanjing medical university	Recruiting	Nanjing	Jiangsu	210029	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D012770	Shock, Cardiogenic
D003324	Coronary Artery Disease
D006333	Heart Failure
D018487	Ventricular Dysfunction, Left
D002303	Cardiac Output, Low

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007423	Intra-Aortic Balloon Pumping

Ancestor Terms

ID	Term
D015908	Counterpulsation
D001243	Assisted Circulation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided