Coronary Artery Bypass SurgeryENDO-ACABNCT02433951
Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
An observational study of Coronary Artery Bypass Surgery, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- Cardiopulmonary exercise test
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing CABG surgery or endo-ACAB surgery.
Who may be able to join
- undergoing this type of surgery. For healthy subjects: must be sedentary.
Who cannot join
- any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- Cardiopulmonary exercise test
- Keywords
- exercise tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testOther
Maximal exercise test with ergospirometry.
| Study group | Role | What they receive |
|---|---|---|
| healthy individuals | Age, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary. Receives: Other: Cardiopulmonary exercise test | |
| CABG patients | Age, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease. Receives: Other: Cardiopulmonary exercise test | |
| endo-ACAB patients | Age, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease. Receives: Other: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak (peak oxygen uptake)
Peak oxygen uptake capacity, expressed as ml/min.
Measured: At peak exercise, single measurement which is executed between 2-4 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Paul Dendale, Study director, Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433951
- Sponsor's protocol ID
- ENDO-ACAB study
- Acronym
- ENDO-ACAB
- Status last verified
- Aug 2015
- First submitted
- 24 Apr 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Tolerance in Patients With Coronary Artery Bypass Surgery (CABG) and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
- ClinicalTrials.gov ID
- NCT02433951
- Acronym / sponsor ID
- ENDO-ACAB / ENDO-ACAB study
- Conditions
- Coronary Artery Bypass Surgery
- Keywords
- exercise tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy individuals | – | Other: Cardiopulmonary exercise testAge, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary. |
| CABG patients | – | Other: Cardiopulmonary exercise testAge, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease. |
| endo-ACAB patients | – | Other: Cardiopulmonary exercise testAge, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing CABG surgery or endo-ACAB surgery.
Key inclusion criteria (1 listed)
- undergoing this type of surgery. For healthy subjects: must be sedentary.
Key exclusion criteria (1 listed)
- any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testMaximal exercise test with ergospirometry. | Other | CABG patients, endo-ACAB patients, healthy individuals |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dendale study director
Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Surgery, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (peak oxygen uptake) (time frame: At peak exercise, single measurement which is executed between 2-4 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.