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

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ClinicalTrials.gov Identifier: NCT02900456
Recruitment Status : Unknown
Verified November 2017 by Rennes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Interventional Cardiology

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Study Type : Observational [Patient Registry]
Actual Enrollment : 177 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018



Primary Outcome Measures :
  1. IABP insertion rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of cardiogenic shock [ Time Frame: 1 year ]
    IABP indications

  2. Number of mechanical complication of acute coronary syndrome [ Time Frame: 1 year ]
    IABP indications

  3. Number of myocardial infarction not shocked [ Time Frame: 1 year ]
    IABP indications

  4. Number of other indications [ Time Frame: 1 year ]
    IABP indications

  5. Survival rate following IABP insertion [ Time Frame: 1 year ]
  6. IABP-related complications rate and type [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900456


Locations
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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, France
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Guillaume LEURENT CHU Rennes

Additional Information:

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02900456     History of Changes
Other Study ID Numbers: 35RC14_8942
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rennes University Hospital:
Intra-aortic Balloon Pumps
Registry