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 Caen; 🇫🇷 Caen, France

Hôpital privé Beauregard; 🇫🇷 Rennes, France

CHU Brest; 🇫🇷 Brest, France

CHU Nantes; 🇫🇷 Nantes, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

Clinique Saint Joseph; 🇫🇷 Angers, France

CH Intercommunal de Cornouaille; 🇫🇷 Quimper, France

CHU Rouen; 🇫🇷 Rouen, France

Groupement Coopération Sanitaire Pui Cite Sanitaire; 🇫🇷 Saint-Nazaire, France

CH Bretagne Atlantique; 🇫🇷 Vannes, France

CHU Rennes; 🇫🇷 Rennes, France

Polyclinique Saint-Laurent; 🇫🇷 Rennes, France

Communauté Hospitalière de Territoire Rance Emeraude; 🇫🇷 Saint-Malo, France

CH Saint-Nazaire; 🇫🇷 Saint-Nazaire, France

CHU Tours; 🇫🇷 Tours, France

Clinique Saint-Hilaire; 🇫🇷 Rouen, France

Clinique Saint Gatien; 🇫🇷 Tours, France

CH Chartres; 🇫🇷 Chartres, France

CHU Angers; 🇫🇷 Angers, France

CH Le Mans; 🇫🇷 Le Mans, France

Hôpital Prive Saint Martin; 🇫🇷 Caen, France

CH Laval; 🇫🇷 Laval, France

CH Bretagne Sud; 🇫🇷 Lorient, France

CH Saint-Brieuc; 🇫🇷 Saint-Brieuc, France

Polyclinique Les Fleurs; 🇫🇷 Toulon, France