The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest

• Conditions: Interventional Cardiology

• Registration Number: NCT02900456
• Lead Sponsor: Rennes University Hospital

Brief Summary

Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Primary Completion: 2017-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Males and females at least of 18 of age;
• Undergoing IABP treatment ;
• Subject, relatives or legal guardian signified their non-opposition to participate in the study

Exclusion Criteria

• IABP insertion in immediate post-intervention period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IABP insertion rate	1 year

Secondary Outcome Measures

Name	Time	Method
Number of cardiogenic shock	1 year	IABP indications
Number of mechanical complication of acute coronary syndrome	1 year	IABP indications
Number of myocardial infarction not shocked	1 year	IABP indications
Number of other indications	1 year	IABP indications
Survival rate following IABP insertion	1 year
IABP-related complications rate and type	1 year

Trial Locations

Locations (25)

CHU Angers; 🇫🇷 Angers, France

Clinique Saint Joseph; 🇫🇷 Angers, France

CHU Brest; 🇫🇷 Brest, France

CHU Caen; 🇫🇷 Caen, France

Hôpital Prive Saint Martin; 🇫🇷 Caen, France

CH Chartres; 🇫🇷 Chartres, France

CH Laval; 🇫🇷 Laval, France

CH Le Mans; 🇫🇷 Le Mans, France

CH Bretagne Sud; 🇫🇷 Lorient, France

CHU Nantes; 🇫🇷 Nantes, France

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