Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03857906
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2019-02-23
Brief Title:
Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery
Sponsor:
CMN 20 de Noviembre
Organization:
CMN 20 de Noviembre
Study Overview
Official Title:
Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery A Single-Centre Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IABP-HR
Brief Summary:
Background The intra-aortic balloon balloon pump IABP has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery CABG Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction AMI the real benefit reducing mortality in the postoperative context PO has not been determined examined through a prospective study with an adequate design
Objective To compare PO complications such as mortality perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls
Objective To compare PO complications such as mortality perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls
Detailed Description:
Methods Quasi-experimental prospective comparative non-randomized study The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team based on the individualized risk benefit The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018 Patients are excluded if any condition is present cardiogenic shock with AMI 48 hours prior and or severe aortic insufficiency In one group BIAC will be inserted 1-6 hours before surgery BIAC group and a second group is control non-BIAC group A minimum 30-day postoperative follow-up of will be performed with primary end points mortality and AMI type V and secondary end points additional PO complications
Analysis An evaluation of normality distribution K-S will be performed the means of quantitative t-Test and categorical variables Fisher or χ² Pearson will be compared A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age sex peripheral arterial disease PAD and EuroSCORE-II on the primary goal Statistical significance will be considered when p 005 Softwares GraphPad-Prism-50 and SPSS-150
Analysis An evaluation of normality distribution K-S will be performed the means of quantitative t-Test and categorical variables Fisher or χ² Pearson will be compared A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age sex peripheral arterial disease PAD and EuroSCORE-II on the primary goal Statistical significance will be considered when p 005 Softwares GraphPad-Prism-50 and SPSS-150
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None