Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT02433951
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2015-04-24', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2peak (peak oxygen uptake)', 'timeFrame': 'At peak exercise, single measurement which is executed between 2-4 weeks after surgery.', 'description': 'Peak oxygen uptake capacity, expressed as ml/min.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise tolerance'], 'conditions': ['Coronary Artery Bypass Surgery']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing CABG surgery or endo-ACAB surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing this type of surgery. For healthy subjects: must be sedentary.\n\nExclusion Criteria:\n\n* any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.'}, 'identificationModule': {'nctId': 'NCT02433951', 'acronym': 'ENDO-ACAB', 'briefTitle': 'Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Exercise Tolerance in Patients With Coronary Artery Bypass Surgery (CABG) and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery', 'orgStudyIdInfo': {'id': 'ENDO-ACAB study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy individuals', 'description': 'Age, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary.', 'interventionNames': ['Other: Cardiopulmonary exercise test']}, {'label': 'CABG patients', 'description': 'Age, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease.', 'interventionNames': ['Other: Cardiopulmonary exercise test']}, {'label': 'endo-ACAB patients', 'description': 'Age, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease.', 'interventionNames': ['Other: Cardiopulmonary exercise test']}], 'interventions': [{'name': 'Cardiopulmonary exercise test', 'type': 'OTHER', 'description': 'Maximal exercise test with ergospirometry.', 'armGroupLabels': ['CABG patients', 'endo-ACAB patients', 'healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Paul Dendale', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Dominique Hansen', 'investigatorAffiliation': 'Hasselt University'}}}}