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

NCT ID: NCT02433951

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Coronary Artery Bypass Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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healthy individuals

Age, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary.

Cardiopulmonary exercise test

Intervention Type OTHER

Maximal exercise test with ergospirometry.

CABG patients

Age, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease.

Cardiopulmonary exercise test

Intervention Type OTHER

Maximal exercise test with ergospirometry.

endo-ACAB patients

Age, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease.

Cardiopulmonary exercise test

Intervention Type OTHER

Maximal exercise test with ergospirometry.

Interventions

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Cardiopulmonary exercise test

Maximal exercise test with ergospirometry.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Dendale

Role: STUDY_DIRECTOR

Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ENDO-ACAB study

Identifier Type: -

Identifier Source: org_study_id

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