Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-18 @ 11:41 AM
Study NCT ID:
NCT02426203
Status:
UNKNOWN
Last Update Posted:
2015-04-28
First Post:
2015-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-04-21', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right ventricular ejection fraction', 'timeFrame': '6 months', 'description': '3-dimensional acquisition of right ventricular ejection fraction using echocardiography'}], 'secondaryOutcomes': [{'measure': 'Tricuspid annular plane systolic excursion', 'timeFrame': '6 months'}, {'measure': 'Right ventricular fractional area change', 'timeFrame': '6 months'}, {'measure': 'Right ventricular strain', 'timeFrame': '6 months'}, {'measure': 'Pulmonary artery acceleration time', 'timeFrame': '6 months'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Echocardiography'], 'conditions': ['Chronic Thromboembolic Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Chronic thromboembolic pulmonary hypertension causes progressive right heart hypertrophy, dilatation and dysfunction. Surgical treatment is pulmonary endarterectomy, which although only carried out in a single UK centre, provides an excellent model for assessing right ventricular function. Right heart function is most commonly assessed using echocardiography, either transthoracic pre- and post-operatively, or transoesophageal intra-operatively. Measurement of tricuspid annular plane systolic excursion is the best validated and most commonly performed measurement for right heart function, however it may be inaccurate after sternotomy and pericardial opening, making accurate assessment difficult immediately after surgery. Therefore, we aim to compare established methods of assessing right heart function with 3-dimensional echocardiographic reconstruction of the ventricle, using a novel reconstruction mechanism. Right ventricular function will be assessed in 51 patients who undergo pulmonary endarterectomy surgery at baseline, after the pericardium has been opened, following the surgical procedure, using transoesophageal echocardiography, and at six-month outpatient followup using transthoracic echocardiography, as 3D-reconstruction is valid using both modalities. This comparison should allow the investigators to determine whether such a method could replace current measurement parameters for assessment of right ventricular function, which is important for clinical management of patients in a variety of settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic thromboembolic pulmonary hypertension who are undergoing pulmonary endarterectomy surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* undergoing pulmonary endarterectomy surgery at Papworth Hospital\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Patient refusal\n* Contraindication to transoesophageal echocardiography\n* Technical difficulty preventing adequate echocardiographic assessment of right heart function'}, 'identificationModule': {'nctId': 'NCT02426203', 'briefTitle': '3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papworth Hospital NHS Foundation Trust'}, 'officialTitle': 'Three-dimensional Echocardiographic Assessment of Right Ventricular Function in Patients Undergoing Pulmonary Endarterectomy', 'orgStudyIdInfo': {'id': 'P02016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Endarterectomy patients', 'description': 'Patients undergoing pulmonary endarterectomy surgery at Papworth Hospital', 'interventionNames': ['Procedure: Pulmonary endarterectomy']}], 'interventions': [{'name': 'Pulmonary endarterectomy', 'type': 'PROCEDURE', 'otherNames': ['Transoesophageal Echocardiography', 'Transthoracic Echocardiography'], 'description': 'Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.', 'armGroupLabels': ['Pulmonary Endarterectomy patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'James E Moore, FANZCA FCICM', 'role': 'CONTACT', 'email': 'james.moore10@nhs.net', 'phone': '44 1480 830 541'}, {'name': 'Andrew A Klein, FRCA FFICM', 'role': 'CONTACT', 'email': 'andrew.klein@nhs.net', 'phone': '44 1480 830 541'}], 'overallOfficials': [{'name': 'Andrew J Roscoe, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Papworth Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}