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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376542
• Other study ID #: CAAE: 67629917.1.0000.5272
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: January 10, 2019

Study information

• Verified date: March 2019
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Surgery--Complications

Intervention

Diagnostic Test:
• Cardiopulmonary Exercise Testing
Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Eduardo Tibirica, MD, PhD

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality after cardiac surgery	number of deaths during the first 30 days after cardiac surgery	30 days