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

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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Surgery--Complications Diagnostic Test: Cardiopulmonary Exercise Testing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Official Title: Cardiopulmonary Exercise Testing as an Outcome Predictor in Coronary Artery Bypass Surgery
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cardiopulmonary exercise testing
All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Diagnostic Test: Cardiopulmonary Exercise Testing
Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery




Primary Outcome Measures :
  1. Mortality after cardiac surgery [ Time Frame: 30 days ]
    number of deaths during the first 30 days after cardiac surgery



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
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.

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): NCT03376542


Locations
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Brazil
National Institute of Cardiology
Rio de Janeiro, Brazil, 21040-360
Sponsors and Collaborators
Eduardo Tibirica, MD, PhD
Investigators
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Study Chair: Eduardo Tibiriça, MD, PhD National Institute of Cardiology, Laranjeiras, Brazil

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Responsible Party: Eduardo Tibirica, MD, PhD, Senior Researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT03376542     History of Changes
Other Study ID Numbers: CAAE: 67629917.1.0000.5272
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases