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Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03376542
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Tracking Information
First Submitted Date  ICMJE November 22, 2017
First Posted Date  ICMJE December 18, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
Mortality after cardiac surgery [ Time Frame: 30 days ]
number of deaths during the first 30 days after cardiac surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Official Title  ICMJE Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Coronary Artery Disease
  • Surgery--Complications
Intervention  ICMJE Diagnostic Test: Cardiopulmonary Exercise Testing
Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery
Study Arms  ICMJE Experimental: Cardiopulmonary exercise testing
All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Intervention: Diagnostic Test: Cardiopulmonary Exercise Testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2017)
60
Actual Study Completion Date  ICMJE January 10, 2019
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03376542
Other Study ID Numbers  ICMJE CAAE: 67629917.1.0000.5272
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
Study Sponsor  ICMJE Eduardo Tibirica, MD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eduardo Tibiriça, MD, PhD National Institute of Cardiology, Laranjeiras, Brazil
PRS Account National Institute of Cardiology, Laranjeiras, Brazil
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP