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

Interventional Cardiology Clinical Trial

— CP-GARO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02900456
• Other study ID #: 35RC14_8942
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2016
• Last updated: November 13, 2017
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: November 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interventional Cardiology

Locations

Country	Name	City	State
France	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	Nouvelles Cliniques Nantaises	Nantes
France	CH Intercommunal de Cornouaille	Quimper
France	CHU Rennes	Rennes
France	Hôpital privé Beauregard	Rennes
France	Polyclinique Saint-Laurent	Rennes
France	CHU Rouen	Rouen
France	Clinique Saint-Hilaire	Rouen
France	CH Saint-Brieuc	Saint-Brieuc
France	Communauté Hospitalière de Territoire Rance Emeraude	Saint-Malo
France	CH Saint-Nazaire	Saint-Nazaire
France	Groupement Coopération Sanitaire Pui Cite Sanitaire	Saint-Nazaire
France	Polyclinique Les Fleurs	Toulon
France	CHU Tours	Tours
France	Clinique Saint Gatien	Tours
France	CH Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IABP insertion rate		1 year
Secondary	Number of cardiogenic shock	IABP indications	1 year
Secondary	Number of mechanical complication of acute coronary syndrome	IABP indications	1 year
Secondary	Number of myocardial infarction not shocked	IABP indications	1 year
Secondary	Number of other indications	IABP indications	1 year
Secondary	Survival rate following IABP insertion		1 year
Secondary	IABP-related complications rate and type		1 year