NCT04405856

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.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

13.9 years

First QC Date

May 26, 2020

Last Update Submit

May 26, 2020

Conditions

Acute Coronary SyndromeCardiogenic ShockCoronary Artery DiseaseHeart FailureLeft Ventricular DysfunctionLow Cardiac Output SyndromePost-cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    30 days after IABP implantation

Secondary Outcomes (1)

  • All-cause mortality

    3 months after IABP implantation

Interventions

Intra Aortic Balloon PumpDEVICE

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.

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving IABP for circulatory support

You may qualify if:

  • Patients receiving IABP for circulatory support

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeShock, CardiogenicCoronary Artery DiseaseHeart FailureVentricular Dysfunction, LeftCardiac Output, Low

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesVentricular DysfunctionSigns and Symptoms

Intervention Hierarchy (Ancestors)

CounterpulsationAssisted CirculationSurgical Procedures, Operative

Study Officials

  • Yong-feng Shao, MD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613DR.HONGLIU@FOXMAIL.COM

Yong-feng Shao, MD

CONTACT

02568303100yfshaojph@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator of Department of Cardiac Surgery

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 28, 2020

Study Start

February 1, 2012

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

CN(1)