Clinical trial NCT02900456: The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
Official title: The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interventional Cardiology
Keywords: Intra-aortic Balloon Pumps
Registry
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intra-aortic Balloon Pumps 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: IABP insertion rate
timeFrame: 1 year
Secondary outcomes:
measure: Number of cardiogenic shock
timeFrame: 1 year
measure: Number of mechanical complication of acute coronary syndrome
timeFrame: 1 year
measure: Number of myocardial infarction not shocked
timeFrame: 1 year
measure: Number of other indications
timeFrame: 1 year
measure: Survival rate following IABP insertion
timeFrame: 1 year
measure: IABP-related complications rate and type
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Angers
country: France
facility: Clinique Saint Joseph
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Caen
country: France
facility: Hôpital Prive Saint Martin
city: Chartres
country: France
facility: CH Chartres
city: Laval
country: France
facility: CH Laval
city: Le Mans
country: France
facility: CH Le Mans
city: Lorient
country: France
facility: CH Bretagne Sud
city: Nantes
country: France
facility: CHU Nantes
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Quimper
country: France
facility: CH Intercommunal de Cornouaille
city: Rennes
country: France
facility: CHU Rennes
city: Rennes
country: France
facility: Hôpital privé Beauregard
city: Rennes
country: France
facility: Polyclinique Saint-Laurent
city: Rouen
country: France
facility: CHU Rouen
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Saint-Brieuc
country: France
facility: CH Saint-Brieuc
city: Saint-Malo
country: France
facility: Communauté Hospitalière de Territoire Rance Emeraude
city: Saint-Nazaire
country: France
facility: CH Saint-Nazaire
city: Saint-Nazaire
country: France
facility: Groupement Coopération Sanitaire Pui Cite Sanitaire
city: Toulon
country: France
facility: Polyclinique Les Fleurs
city: Tours
country: France
facility: CHU Tours
city: Tours
country: France
facility: Clinique Saint Gatien
city: Vannes
country: France
facility: CH Bretagne Atlantique
Study officials:
affiliation: CHU Rennes
name: Guillaume LEURENT
role: PRINCIPAL_INVESTIGATOR
References: