Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT05060302
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of a major cardiovascular event (MACE)', 'timeFrame': 'day 30', 'description': 'MACE is a composite criteria. MACES criteria is defined as the occurrence of at least one of the following events: A cardiovascular death or a documented supraventricular tachycardia (atrial fibrillation and/or flutter) of duration \\> 30 seconds or, an acute myocardial infarction or, an hospitalization for a right ventricular failure or, an hospitalization for a left ventricular failure.'}], 'secondaryOutcomes': [{'measure': 'Variation of RV systolic function from baseline in patients with MACE', 'timeFrame': 'at day 1'}, {'measure': 'Variation of RV systolic function from baseline in patients without MACE', 'timeFrame': 'at day 1'}, {'measure': 'Variation of RV systolic function from baseline in patients with MACE', 'timeFrame': 'at day 2'}, {'measure': 'Variation of RV systolic function from baseline in patients without MACE', 'timeFrame': 'at day 2'}, {'measure': 'Variation of RV systolic function from baseline in patients with MACE', 'timeFrame': 'at day 15'}, {'measure': 'Variation of RV systolic function from baseline in patients without MACE', 'timeFrame': 'at day 15'}, {'measure': 'Variation of RV systolic function from baseline in patients with MACE', 'timeFrame': 'within day 30'}, {'measure': 'Variation of RV systolic function from baseline in patients without MACE', 'timeFrame': 'within day 30'}, {'measure': 'Assessment of RV systolic function preoperatively', 'timeFrame': 'at day 30'}, {'measure': 'occurrence of a postoperative complication', 'timeFrame': 'at day 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Right ventricle', 'speckle tracking', 'thoracic surgery'], 'conditions': ['Right Ventricle', 'Thoracic Surgery']}, 'descriptionModule': {'briefSummary': 'In postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. Right ventricular (RV) dysfunction is a complication that can be multifactorial in post thoracic surgery. The RV longitudinal shortening fraction (RV-LSF) is a new 2D-STE parameters able to more accurately detect patients with RV dysfunction compared to conventional echocardiographic parameters.\n\nThis project is a single-center, prospective, interventional study of patients hospitalized at the Amiens University Hospital for scheduled thoracic surgery. TTE is performed preoperatively, at day 2 and day 15 following the thoracic surgery. Echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. MACE criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (\\>18 years)\n* Patient hospitalized at the Amiens University Hospital for scheduled thoracic surgery (lobectomy, pneumonectomy, wedge resection).\n* Surgery by thoracotomy or video-assisted thoracic surgery\n* Information of the patient and collection of his non-opposition\n\nExclusion Criteria:\n\n* Patient with poor echogenicity on TTE not allowing evaluation of 2D-STE or conventional parameters of the RV.\n* Patient with a rapid supraventricular rhythm disorder (HR \\> 100) at the time of TTE\n* Patient under mechanical ventilation\n* Patient under extracorporeal membrane oxygenation\n* Patients under guardianship or legal protection\n* Patients whose clinical condition does not allow for their non-opposition\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT05060302', 'acronym': 'SPECKLETHO', 'briefTitle': 'Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study', 'orgStudyIdInfo': {'id': 'PI2021_843_0030'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transthoracic echocardiography (TTE)', 'type': 'OTHER', 'description': 'the included patients have a TTE preoperatively in order to evaluate the RV systolic function. TTE will also be done at day 2 and day-15 during the follow-up surgical consultation.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christophe Beyls, MD', 'role': 'CONTACT', 'email': 'Beyls.Christophe@chu-amiens.fr', 'phone': '0322087866'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Christophe Beyls, MD', 'role': 'CONTACT', 'email': 'Beyls.Christophe@chu-amiens.fr', 'phone': '0322087866'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}