Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Primary Purpose
Coronary Artery Disease, Surgery--Complications
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cardiopulmonary Exercise Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing coronary artery bypass grafting surgery at the National Institute of Cardiology, Ministry of Health, Rio de Jnaeiro, Brazil.
Exclusion Criteria:
- Angina CCS IV, heart failure NYHA IV, inability to walk on a treadmill, severe left main coronary artery lesion.
Sites / Locations
- National Institute of Cardiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiopulmonary exercise testing
Arm Description
All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Outcomes
Primary Outcome Measures
Mortality after cardiac surgery
number of deaths during the first 30 days after cardiac surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT03376542
First Posted
November 22, 2017
Last Updated
March 11, 2019
Sponsor
Eduardo Tibirica, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT03376542
Brief Title
Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Official Title
Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Tibirica, MD, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a prospective cohort study of patients undergoing coronary artery bypass graft surgery. Prior to surgery, participants will undergo submaximal cardiopulmonary exercise testing on a treadmill. Participants will be followed for one month after surgery to assess mortality and non fatal complications.
Detailed Description
Coronary artery bypass surgery (CABG) is a complex and expensive procedure with great potential for morbidity and mortality. Preoperative evaluation is of paramount importance to optimize results. There is much evidence about the benefits of the cardiopulmonary exercise testing (CPET) in the evaluation of preoperative risk in non-cardiac surgeries. Thus, it is important to evaluate the relationship between parameters obtained in the CPET and the outcomes after cardiac surgery, especially CABG.
This is a prospective cohort study in which participants undergo submaximal CEPT on a treadmill prior to CABG. Participants will be followed up for one month after surgery to assess mortality and non fatal complications. It is expected that poor cardiopulmonary fitness is related to worse outcomes in CABG, as already observed in other cardiac pathologies and in non-cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Surgery--Complications
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiopulmonary exercise testing
Arm Type
Experimental
Arm Description
All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiopulmonary Exercise Testing
Intervention Description
Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery
Primary Outcome Measure Information:
Title
Mortality after cardiac surgery
Description
number of deaths during the first 30 days after cardiac surgery
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing coronary artery bypass grafting surgery at the National Institute of Cardiology, Ministry of Health, Rio de Jnaeiro, Brazil.
Exclusion Criteria:
Angina CCS IV, heart failure NYHA IV, inability to walk on a treadmill, severe left main coronary artery lesion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Tibiriça, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Laranjeiras, Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
National Institute of Cardiology
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
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