Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery (ENDO-ACAB)

August 17, 2015 updated by: Dominique Hansen, Hasselt University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

55

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

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Hospital

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing CABG surgery or endo-ACAB surgery.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy individuals
Age, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary.
Other: Cardiopulmonary exercise test
Maximal exercise test with ergospirometry.
CABG patients
Age, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease.
Other: Cardiopulmonary exercise test
Maximal exercise test with ergospirometry.
endo-ACAB patients
Age, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease.
Other: Cardiopulmonary exercise test
Maximal exercise test with ergospirometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2peak (peak oxygen uptake)
Time Frame: At peak exercise, single measurement which is executed between 2-4 weeks after surgery.
Peak oxygen uptake capacity, expressed as ml/min.
At peak exercise, single measurement which is executed between 2-4 weeks after surgery.

Collaborators and Investigators

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

Sponsor

Hasselt University

Investigators

  • Study Director: Paul Dendale, Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium

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

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ENDO-ACAB study

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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