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

NCT ID: NCT03376542

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-01-10

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.

Conditions

Coronary Artery Disease; Surgery--Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiopulmonary exercise testing

All patients included in the study will perform cardiopulmonary exercise testing prior to surgery

Group Type: EXPERIMENTAL

Cardiopulmonary Exercise Testing

Intervention Type: DIAGNOSTIC_TEST

Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery

Interventions

Cardiopulmonary Exercise Testing

Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eduardo Tibirica, MD, PhD

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eduardo Tibirica, MD, PhD

Senior Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eduardo Tibiriça, MD, PhD

Role: STUDY_CHAIR

National Institute of Cardiology, Laranjeiras, Brazil

Locations

National Institute of Cardiology

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

CAAE: 67629917.1.0000.5272

Identifier Type: -

Identifier Source: org_study_id