Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-29 @ 4:46 PM
Study NCT ID:
NCT06366061
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2022-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Comparison of high Frame Rate (FR) vs. low FR of the following measures: [ i) S'STE AP4C supine, ii) GLS AP4C supine, iii) SR AP4C supine]", 'timeFrame': 'This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)', 'description': 'With high Frame Rate (FR) the measures will be more exact than with low FR'}, {'measure': "Comparison of the measured values in the cardiological gold standard (Left lateral decubitus (LLD)) vs. supine, for the following values [ i) S'TDI AP4C, ii) S'STE AP4C, iii) GLS]", 'timeFrame': 'This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)', 'description': 'Comparison of values in different patient position for TTE'}], 'primaryOutcomes': [{'measure': "S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine", 'timeFrame': 'This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)', 'description': '\\- Comparison of two velocities measured by two different methods.'}], 'secondaryOutcomes': [{'measure': 'Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function?', 'timeFrame': 'This is going to be assessed after the trans thoracic echocardiography, through study completion (an average of 1 year)', 'description': '* Correlation: GLS, AP4C, supine vs. GLS, SC4C supine\n* Bland Altman (BA) Plot: GLS, AP4C, supine vs. GLS, SC4C supine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Functional Disturbances During Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning.', 'detailedDescription': 'In transthoracic echocardiography, a number of measures are endorsed by current guidelines for quantifying ventricular function. These include conventional (mitral annular plane velocities, ejection fraction) and novel, speckle-tracking (STE) technologies. However, these measurements are standardized to be measured in the left lateral decubitus position in the apical (4-chamber) view of awake spontaneously breathing patients.\n\nIn the perioperative period, however, attaining these measurements in the endorsed circumstances may be challenging for a number of reasons. First, obtaining usable AP4C images may be difficult in ventilated or post-surgical patients. While the SC4C is generally obtainable visualized structures are not identical to those of the AP4C and measurement technologies such as Doppler are misaligned Secondly, patient conditions (e.g. in distress, or during surgery) may preclude positioning the patient in the left lateral decubitus position. Finally, patients may be ventilated and under anesthesia.\n\nNewer technologies - such as speckle-tracking- may partially overcome these difficulties as these technologies are considered to be relatively angle independent. For quantification, it would be important to know whether or not speckle-tracking based measurements in the SC4C are sufficiently close to those measured under the endorsed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective non-cardiac surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting adult patients undergoing elective non-cardiac surgery\n\nExclusion Criteria:\n\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,\n* Previous enrolment into the current study,\n* Emergency procedures mandating expeditive patient care,\n* Nonregular heart rhythm\n* Valvular heart disease in the LV at least midgrade'}, 'identificationModule': {'nctId': 'NCT06366061', 'briefTitle': 'A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING: A PROSPECTIVE, CLINICAL TRIAL', 'orgStudyIdInfo': {'id': '2020-02868'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Randomization', 'description': 'A randomization will be done for the order of the different TTE measurments, but all patients are going the same TTE measurements after all'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Basel', 'state': 'Canton of Basel-City', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Michael Lampart, Prakt. med.', 'role': 'CONTACT', 'email': 'michael.lampart@usb.ch', 'phone': '+41764006180'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Michael Lampart, Prakt. med.', 'role': 'CONTACT', 'email': 'michael.lampart@usb.ch', 'phone': '+41 61 328 64 77'}, {'name': 'Eckhard Mauermann, PD', 'role': 'CONTACT', 'email': 'eckhard.mauermann@usb.ch', 'phone': '+41 61 328 73 87'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eckhard Mauermann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD', 'investigatorFullName': 'Eckhard Mauermann', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}