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

March 11, 2019 updated by: Eduardo Tibirica, MD, PhD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • National Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality after cardiac surgery
Time Frame: 30 days
number of deaths during the first 30 days after cardiac surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eduardo Tibirica, MD, PhD

Investigators

  • Study Chair: Eduardo Tibiriça, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 67629917.1.0000.5272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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