Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT03115294
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Image Correlation in Right Ventricular Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013806', 'term': 'Theophylline'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'video analysts do not get information of the clinical data or procedure phase'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients undergo medication intervention (w/intravenous theophylline) and ventilator volume adjustements, and serial ventricular function parameters are compared (pre-and post-intervention measurements).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ECG', 'timeFrame': 'Within the operation', 'description': 'Simultaneous ECG recording and analysis during outcome 4 measurements'}, {'measure': 'Transesophageal ultrasound', 'timeFrame': 'Within the operation', 'description': 'Myocardial contraction range during video-clip'}, {'measure': 'Cardiac output', 'timeFrame': 'Within the operation', 'description': 'Measurement of cardiac output'}], 'primaryOutcomes': [{'measure': 'Heart ventricle function', 'timeFrame': 'Within the operation', 'description': 'Changes in heart ventricle contraction status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Ventricles']}, 'referencesModule': {'references': [{'pmid': '31847587', 'type': 'RESULT', 'citation': 'Soltani A, Lahti J, Jarvela K, Laurikka J, Kuokkala VT, Hokka M. Characterization of the anisotropic deformation of the right ventricle during open heart surgery. Comput Methods Biomech Biomed Engin. 2020 Feb;23(3):103-113. doi: 10.1080/10255842.2019.1703133. Epub 2019 Dec 17.'}, {'pmid': '29717224', 'type': 'RESULT', 'citation': 'Soltani A, Lahti J, Jarvela K, Curtze S, Laurikka J, Hokka M, Kuokkala VT. An Optical Method for the In-Vivo Characterization of the Biomechanical Response of the Right Ventricle. Sci Rep. 2018 May 1;8(1):6831. doi: 10.1038/s41598-018-25223-z.'}]}, 'descriptionModule': {'briefSummary': 'Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.', 'detailedDescription': 'Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* open heart surgery, patient acceptance and informed consent, age 75 or more\n\nExclusion Criteria:\n\n* patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.'}, 'identificationModule': {'nctId': 'NCT03115294', 'acronym': 'CardiomeDIC', 'briefTitle': 'Digital Image Correlation in Right Ventricular Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'R16045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning', 'interventionNames': ['Drug: Theophylline', 'Procedure: Ventilator positive end expiratory pressure adjustment', 'Device: Videorecording']}], 'interventions': [{'name': 'Theophylline', 'type': 'DRUG', 'description': 'iv injection', 'armGroupLabels': ['Study group']}, {'name': 'Ventilator positive end expiratory pressure adjustment', 'type': 'PROCEDURE', 'description': 'Positive end-expiratory pressure variation', 'armGroupLabels': ['Study group']}, {'name': 'Videorecording', 'type': 'DEVICE', 'description': 'Myocardial movement videorecording', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital, Heart Center', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Jari Laurikka, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Cardio-thoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'non-identifiable data to Tampere University of Technology research group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jari Laurikka', 'investigatorAffiliation': 'Tampere University Hospital'}}}}