Status:
COMPLETED
Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery
Lead Sponsor:
CMN "20 de Noviembre"
Collaborating Sponsors:
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Conditions:
Ischemic Cardiomyopathy
Heart Failure
Eligibility:
All Genders
18-99 years
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 (C...
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, base...
Eligibility Criteria
Inclusion
- All patients greater than 18 years
- Scheduled for coronary artery bypass graft (CABG) surgery were eligible
- Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (\>50%)
- Written informed consent provided
Exclusion
- Prior cardiogenic shock,
- Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
- Previous IABP use
- AMI mechanical complications
- Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
- Tachyarrhythmia
- Other aortic procedures
- Other non-CABG surgical procedures
- Massive pulmonary embolism
- Older than 90 years of age
- Any coagulopathy
- Severe concomitant disease associated with a life expectancy of less than 6 months.
Key Trial Info
Start Date :
October 21 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 19 2019
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03857906
Start Date
October 21 2014
End Date
January 19 2019
Last Update
March 6 2019
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