Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery

Coronary Artery Bypass Surgery Clinical Trial

— ENDO-ACAB  

Official title:

Exercise Tolerance in Patients With Coronary Artery Bypass Surgery (CABG) and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433951
• Other study ID #: ENDO-ACAB study
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: August 17, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only). Exercise tolerance is compared between groups.

Description:

In this prospective observational study, up to 20 healthy individuals (no history or presence of any chronic disease, sedentary), 20 endo-ACAB patients, and 20 CABG patients (matched for age, gender and BMI) undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only).During this exercise test, following parameters are assessed at peak effort and at the second ventilatory threshold (determined by VE/VCO2 slope method): oxygen uptake (VO2), oxygen saturation (SaO2), carbon dioxide output (VCO2), resoiratory gas exchange ratio (RER), expiratory volume (VE), ventilatory equivalent for VCO2 (VE/VCO2), ventilatory equivalent for VO2 (VE/VO2), end-tidal O2 pressure (PETO2), end-tidal CO2 pressure (PETCO2), heart rate (HR), oxygen pulse (VO2/HR), cycling power output (W), tidal volume (Vt), respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure (DBP), rate pressure product (RPP). Peak exercise effort is validated by RERpeak.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• undergoing this type of surgery. For healthy subjects: must be sedentary.

Exclusion Criteria:

• any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery

Intervention

Other:
• Cardiopulmonary exercise test
Maximal exercise test with ergospirometry.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2peak (peak oxygen uptake)	Peak oxygen uptake capacity, expressed as ml/min.	At peak exercise, single measurement which is executed between 2-4 weeks after surgery.	No