Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT06409234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Pathology', 'timeFrame': '30 days', 'description': "Decreased contractility (LVEF ≤40% by Simpson's method or eyeballing) or based on corresponding qualitative statement in TTE report. Significant LV diastoic: E/A \\<0.8 + E\\>50cm/sec OR E/A \\>0.8 to \\<2 + at least ≥ 2 additional criteria ( Average E/e' ratio \\>14, peak TR velocity \\>2,8 m/sec, LA volume index \\>34 mL/m2."}], 'secondaryOutcomes': [{'measure': 'Disability-free survival at 30 days', 'timeFrame': '30 days', 'description': 'WHODAS scale-none=0 to extreme=4, for a total maximal score of 48 and transformed into the percentage of maximal disability score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transthoracic echocardiography'], 'conditions': ['Elective Surgical Procedure']}, 'descriptionModule': {'briefSummary': 'In August 2022 the European Society of Cardiology published updated guidelines including recommendations on preoperative transthoracic echocardiography. The update resulted in broadened criteria for preoperative transthoracic echocardiography. The impact of preoperative transthoracic echocardiography on outcome is controversial and the evidence was mostly derived from administrative databases. Also there is also a knowledge gap in terms of what changes in perioperative managements are derived from transthoracic echocardiography information in current daily practice in Europe and what their impact on outcome may be. Further, a secondary analysis in a large international cohort suggests that the criteria endorsed by the guidelines to define the class of recommendation of transthoracic echocardiography may not be efficient.', 'detailedDescription': 'The target population consists of patients at elevated cardiovascular risk undergoing elective, intermediate or high-risk noncardiac surgery. The planned sample size is 5500 exposed and 2750 non-exposed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'EuPreCHO is a prospective, international, case control study. RQ3 will be assessed in a cohort consisting of the cases only. Any hospital in Europe (as defined by the World Health Organisation) is welcome to participate as a study centre. Study centre registration occurs online via the dedicated Call for Centres form on the ESAIC website. Centres will be asked to enroll a minimum of 50 cases and 25 controls within the 12-month period planned for EuPreCHO enrollment. Within the enrollment period, the start of recruitment for individual centres is at the discretion of the local PI, provided that there is a prior IRB approval. Recruitment across all centres will continue until enrollment of the planned sample size.', 'eligibilityCriteria': 'Inclusion Criteria\n\n* aged ≥65 years OR\n* above 18 years and presenting ≥2 cardiovascular risk factors (hypertension, smoking, dyslipidaemia, diabetes, family history of CVD) OR\n* above 18 years with known cardiovascular disease\n\nExclusion Criteria\n\n* under 18 years of age\n* day surgery\n* urgent/emergency procedures\n* current ICU patient (i.e. in ICU on day-1 or the day of the index surgery (day 0)),\n* cardiac surgery within the last month prior according to the index noncardiac procedure (of note this does not include cardiological interventions like TAVI or valvuloplasty),\n* unwilling or unable to provide informed consent,\n* unable to complete the WHODAS questionnaire (literacy or language barrier)\n* Previous enrollment in EuPreCHO (in case of repeated surgery)'}, 'identificationModule': {'nctId': 'NCT06409234', 'briefTitle': 'Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'European Society of Anaesthesiology'}, 'officialTitle': 'EuPreCHO: European Study on Perioperative Management and Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients', 'orgStudyIdInfo': {'id': 'EuPreCHO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed group', 'description': '5500 exposed group will be patients in whom Transthoracic Echocardiography was performed within 3 months before surgery. Controls will be patients in whom Transthoracic Echocardiography was NOT performed.', 'interventionNames': ['Other: Transthoracic Echocardiography Recieved']}], 'interventions': [{'name': 'Transthoracic Echocardiography Recieved', 'type': 'OTHER', 'description': 'Transthoracic Echocardiography Recieved', 'armGroupLabels': ['Exposed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'University Hospital Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Saman Sepehr', 'role': 'CONTACT', 'email': 'saman.sepehr@esaic.org', 'phone': '3222273999'}], 'overallOfficials': [{'name': 'Giovanna Lurati Buse, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heinrich-Heine University, Duesseldorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Society of Anaesthesiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}