The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
CP-GARO
1 other identifier
observational
177
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedNovember 14, 2017
November 1, 2017
2 years
August 26, 2016
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IABP insertion rate
1 year
Secondary Outcomes (6)
Number of cardiogenic shock
1 year
Number of mechanical complication of acute coronary syndrome
1 year
Number of myocardial infarction not shocked
1 year
Number of other indications
1 year
Survival rate following IABP insertion
1 year
- +1 more secondary outcomes
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- \- IABP insertion in immediate post-intervention period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
CH Saint-Nazaire
Saint-Nazaire, France
Groupement Coopération Sanitaire Pui Cite Sanitaire
Saint-Nazaire, France
Communauté Hospitalière de Territoire Rance Emeraude
St-Malo, France
Polyclinique Les Fleurs
Toulon, France
CHU Tours
Tours, France
Clinique Saint Gatien
Tours, France
CH Bretagne Atlantique
Vannes, France
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume LEURENT
CHU Rennes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
September 14, 2016
Study Start
January 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2018
Last Updated
November 14, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share