Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-18 @ 9:04 PM
Study NCT ID:
NCT06702059
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiopulmonary Exercise Testing in Cardiosurgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-11-20', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-operative pulmonary complications', 'timeFrame': 'within 30 post-operative days', 'description': 'pneumonia, atelectasis, respiratory failure, ARDS'}, {'measure': 'post-operative cardiovascular complications', 'timeFrame': 'within 30 post-operative days', 'description': 'new arrhythmias (atrial fibrillation, supraventricular tachycardia, etc.), myocardial infarction/minimal myocardial lesion, hypotension, heart failure, pulmonary edema, pulmonary embolism, cardiopulmonary resuscitation'}], 'secondaryOutcomes': [{'measure': 'Hospital and Intensive care length of stay', 'timeFrame': 'within 30 post-operative days', 'description': 'Hospital and Intensive care length of stay'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiovascular surgery', 'cardiopulmonary exercise testing', 'post-operative complications'], 'conditions': ['Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '27496629', 'type': 'BACKGROUND', 'citation': 'Brat K, Tothova Z, Merta Z, Taskova A, Homolka P, Vasakova M, Skrickova J, Sramek V, Olson LJ, Cundrle I Jr. Resting End-Tidal Carbon Dioxide Predicts Respiratory Complications in Patients Undergoing Thoracic Surgical Procedures. Ann Thorac Surg. 2016 Nov;102(5):1725-1730. doi: 10.1016/j.athoracsur.2016.05.070. Epub 2016 Aug 3.'}, {'pmid': '36891072', 'type': 'BACKGROUND', 'citation': 'Cundrle I Jr, Merta Z, Bratova M, Homolka P, Mitas L, Sramek V, Svoboda M, Chovanec Z, Chobola M, Olson LJ, Brat K. The risk of post-operative pulmonary complications in lung resection candidates with normal forced expiratory volume in 1 s and diffusing capacity of the lung for carbon monoxide: a prospective multicentre study. ERJ Open Res. 2023 Mar 6;9(2):00421-2022. doi: 10.1183/23120541.00421-2022. eCollection 2023 Mar.'}, {'pmid': '32085879', 'type': 'BACKGROUND', 'citation': 'Mann J, Williams M, Wilson J, Yates D, Harrison A, Doherty P, Davies S. Exercise-induced myocardial dysfunction detected by cardiopulmonary exercise testing is associated with increased risk of mortality in major oncological colorectal surgery. Br J Anaesth. 2020 Apr;124(4):473-479. doi: 10.1016/j.bja.2019.12.043. Epub 2020 Feb 19.'}, {'pmid': '22560968', 'type': 'BACKGROUND', 'citation': 'Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.'}, {'pmid': '35074321', 'type': 'BACKGROUND', 'citation': 'Brat K, Homolka P, Merta Z, Chobola M, Heroutova M, Bratova M, Mitas L, Chovanec Z, Horvath T, Benej M, Ivicic J, Svoboda M, Sramek V, Olson LJ, Cundrle I Jr. Prediction of Postoperative Complications: Ventilatory Efficiency and Rest End-tidal Carbon Dioxide. Ann Thorac Surg. 2023 May;115(5):1305-1311. doi: 10.1016/j.athoracsur.2021.11.073. Epub 2022 Jan 21.'}, {'pmid': '17989266', 'type': 'BACKGROUND', 'citation': 'Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.'}]}, 'descriptionModule': {'briefSummary': 'Cardiopulmonary exercise testing (CPET) is considered to be a gold standard in pre-operative risk assessment and stratification of high risk patients scheduled for major surgery. Surprisingly, only a limited number of studies examined the prognostic role of CPET in cardiothoracic surgery. This is in contrast with rather poor discriminating quality of cardiovascular surgery risk scores and predominantly elderly cardiovascular surgery patients, with significant comorbidity and high degree of frailty. Recently, CPET was shown feasible in coronary artery bypass grafting surgery candidates. Additionally, the rest parameter, which is the partial pressure of end-tidal carbon dioxide (PETCO2) and a submaximal exercise parameter (the VE/VCO2 slope) with good prognostic utility across multiple respiratory exchange ratio values), has been shown to predict mortality and post-operative complications.\n\nWhether these rest and submaximal exercise parameters can be used to predict postoperative complications in cardiovascular surgery patients is yet to be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for coronary artery bypass graft surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for coronary artery bypass graft surgery\n\nExclusion Criteria:\n\n* not able to perform cardiopulmonary exercise testing, off-pump revascularization, without full sternotomy, previous cardiac surgery'}, 'identificationModule': {'nctId': 'NCT06702059', 'briefTitle': 'Cardiopulmonary Exercise Testing in Cardiosurgery Patients', 'organization': {'class': 'OTHER', 'fullName': "St. Anne's University Hospital Brno, Czech Republic"}, 'officialTitle': 'Cardiopulmonary Exercise Testing in the Prediction of Post-operative Complications in Patients Undergoing Coronary Artery Bypass Graft Surgery', 'orgStudyIdInfo': {'id': '46/2024/OD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary artery bypass graft candidates', 'description': 'patients scheduled for CABG surgery will undergo pre-operative cardiopulmonary exercise testing and post-operative complications monitoring', 'interventionNames': ['Diagnostic Test: Cardiopulmonary exercise testing']}], 'interventions': [{'name': 'Cardiopulmonary exercise testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects will undergo pre-operative cardiopulmonary exercise testing.', 'armGroupLabels': ['coronary artery bypass graft candidates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60200', 'city': 'Brno', 'state': 'Czech Republic', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Marek Lukes, M.D.', 'role': 'CONTACT', 'email': 'mare.lukes@fnusa.cz', 'phone': '00 420 543 182 484'}, {'name': 'Petr Fila, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marek Sebo, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marek Lukes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre of Cardiovascular and Transplantation Surgery', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '61200', 'city': 'Brno', 'state': 'Czech Republic', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Czechia', 'facility': "St. Anne's University Hospital in Brno", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'centralContacts': [{'name': 'Ivan Cundrle, prof., M.D.', 'role': 'CONTACT', 'email': 'Ivan.Cundrle@fnusa.cz', 'phone': '00420 543182553'}, {'name': 'Marek Lukes, M.D.', 'role': 'CONTACT', 'email': 'marek.lukes@cktch.cz', 'phone': '00 420 543 182 484'}], 'overallOfficials': [{'name': 'Ivan Cundrle, prof., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Anne's University Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Information will be provided upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre of Cardiovascular and Transplantation Surgery, Czech Republic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ivan Cundrle', 'investigatorAffiliation': "St. Anne's University Hospital Brno, Czech Republic"}}}}