Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT05859620
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-23', 'size': 1782371, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-13T05:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)', 'timeFrame': 'during the hospital stay (up to postoperative day 2)', 'description': 'Percentage of patients eligible for PMI-screening according to inclusion criteria, but not screened during the implementation phase (defined as no or only one measurement of hs-cTn done during screening days)'}, {'measure': 'Incidence of PMI', 'timeFrame': 'after the surgery until postoperative day 2', 'description': 'Percentage of patients experiencing PMI following noncardiac surgery'}, {'measure': 'Cardiology consultation (Fidelity)', 'timeFrame': 'during hospital stay (up to postoperative day 5)', 'description': 'Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist'}, {'measure': 'Diagnostic challenge', 'timeFrame': 'during hospital stay (up to postoperative day 5)', 'description': 'Number of cases with mismatch of initial classification of PMI aetiology (and management pathway) at time of consultation versus final adjudication. In case of two differential diagnoses stated on the cardiology consultation, mismatch is seen when none of the diagnoses correspond to the final adjudication. If three or more differential diagnoses are stated, mismatch is seen in any case even if the final adjudication diagnosis is stated'}, {'measure': 'Barriers to implementation', 'timeFrame': 'following the post-implementation period (6 months after implementation)', 'description': 'Barriers to implementation will be assessed by a semi-quantitive questionnaire complemented by qualitative focus group including the local investigators and representatives of cardiology and anaesthesiology'}], 'secondaryOutcomes': [{'measure': 'Medicoeconomic impact', 'timeFrame': 'Within 3 - 30 days following surgery', 'description': 'Cost of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days, denoted in Swiss Francs'}, {'measure': 'Resource Usage', 'timeFrame': 'Within 3 - 30 days following surgery', 'description': 'Number of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days'}, {'measure': 'Major adverse cardiac events (MACE)', 'timeFrame': '1 year', 'description': 'Occurrence and timing of a composite of major adverse cardiac events (MACE) within twelve months, consisting of: All-cause death, acute myocardial infarction Type 1, survived sudden cardiac death, and Acute heart failure'}, {'measure': 'Complications of cardiology diagnostics', 'timeFrame': '30 days', 'description': 'Number of inappropriate interventions or complications of cardiology diagnostics and interventions, consisting of: Overtreatment (Coronary angiographies showing normal coronaries), complications of cardiac interventions (myocardial infarction, stroke, death)'}, {'measure': 'Major bleeding', 'timeFrame': 'Postoperative day 1 - 1 year (blinding of first 24h following surgery)', 'description': 'Bleeding Academic Research Consortium Typ 3-5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial injury', 'Myocardial infarction', 'Perioperative care', 'Noncardiac surgery', 'Screening'], 'conditions': ['Myocardial Injury', 'Myocardial Infarction', 'Perioperative Complication']}, 'descriptionModule': {'briefSummary': 'The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients.\n\nSpecifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.', 'detailedDescription': 'Background: Perioperative myocardial infarction/injury (PMI) is increasingly recognised as frequent, but often undiagnosed and untreated contributor to mortality following noncardiac surgery. Due to differences in pathophysiology and perioperative anaesthesia and analgesia, most PMI do not cause typical ischemic symptoms and are therefore missed in routine clinical practice. Active surveillance using cardiac troponin (cTn) is now guideline-recommended for the early detection of PMI to possibly improve outcome1. Given substantial concerns regarding the feasibility and health economic impact of implementing such a strategy, it is not yet widely applied.\n\nAim: to show feasibility of implementation as well as health economic impact of an active surveillance for the early detection of PMI in high-risk patients.\n\nMethodology: in this observational before-after study the investigators will enrol patients at high cardiovascular risk undergoing noncardiac surgery before and after implementation of a PMI screening. Patients in the pre-implementation phase will receive standard of care, while in the post-implementation phase patients receive a PMI-screening, consisting of a preoperative and two postoperative measurements of high-sensitivity cTn (hs-cTn) and a cardiology consultation will be done in case of detection of a PMI. Patient data, resource utilisation, and PMI-aetiology will be collected. Interviews with key stakeholders will identify barriers to implementation. One-year follow-up will be conducted to evaluate occurrence of death, MACE, and safety endpoints.\n\nPotential significance: This study will generate important insights regarding the feasibility, safety and the health economic impact of implementing an active surveillance for the early detection of PMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 40-85 years at increased cardiovascular risk undergoing inpatient, noncardiac, elective or emergent surgery with a planned postoperative stay of ≥2 nights', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients fulfilling the institutional criteria for inclusion into the routine PMI-screening\n* aged 40-85 years\n* at increased cardiovascular risk\n* undergoing inpatient, noncardiac, elective or emergent surgery\n* postoperative stay of ≥2 nights at the participating institution\n* orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, and visceral surgery.\n\nExclusion Criteria:\n\n* patients with cardiac surgery or interventions in the last 14 days\n* chronic renal failure under dialysis, renal transplant surgery\n* moderate-to-severe dementia\n* previous inclusion within 5 days\n* documented refusal to use of their data for research purposes or refusal of further use during follow-up\n* Patients declining consent for follow-up will be excluded from follow-up analyses.'}, 'identificationModule': {'nctId': 'NCT05859620', 'acronym': 'ImplementPMI', 'briefTitle': 'Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact', 'orgStudyIdInfo': {'id': '2020-02899'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before implementation', 'description': 'Patients included before implementation of the PMI-screening', 'interventionNames': ['Other: Patient assessment and follow-up']}, {'label': 'After implementation', 'description': 'Patients included after implementation of the PMI-screening', 'interventionNames': ['Other: Patient assessment and follow-up']}], 'interventions': [{'name': 'Patient assessment and follow-up', 'type': 'OTHER', 'description': 'There is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study.', 'armGroupLabels': ['After implementation', 'Before implementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Judith Martini, MD, PD', 'role': 'CONTACT', 'email': 'judith.martini@tirol-kliniken.at', 'phone': '+43 512 504 80478'}, {'name': 'Petra Hillinger, MD', 'role': 'CONTACT', 'email': 'petra.hillinger@tirol-kliniken.at', 'phone': '+43 512 504 80449'}, {'name': 'Judith Martini, MD, PD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Petra Hillinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Axel Bauer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1205', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Bernardo Bollen Pinto, MD, PhD', 'role': 'CONTACT', 'email': 'bernardo.bollenpinto@hcuge.ch', 'phone': '+41 795532125'}, {'name': 'Bernardo Bollen Pinto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '6000', 'city': 'Lucerne', 'state': 'Canton of Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Matthias Bossard, MD', 'role': 'CONTACT', 'email': 'matthias.bossard@luks.ch', 'phone': '+41 41 205 14 77'}, {'name': 'Matthias Bossard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cantonal Hospital Lucerne', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}, {'zip': '4600', 'city': 'Olten', 'state': 'Canton of Solothurn', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Switzerland', 'facility': 'Canton Hospital Olten', 'geoPoint': {'lat': 47.34999, 'lon': 7.90329}}, {'zip': '4500', 'city': 'Solothurn', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nisha Arenja, PD', 'role': 'CONTACT', 'email': 'nisha.arenja@spital.so.ch', 'phone': '0041 62 311 41 30'}, {'name': 'Nisha Arenja, PD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bürgerspital Solothurn', 'geoPoint': {'lat': 47.20791, 'lon': 7.53714}}], 'centralContacts': [{'name': 'Christian Puelacher, MD-PhD', 'role': 'CONTACT', 'email': 'christian.puelacher@usb.ch', 'phone': '+41 76 403 44 50'}, {'name': 'Christian Müller, Prof.', 'role': 'CONTACT', 'email': 'christian.mueller@usb.ch', 'phone': '+41 61 328 65 49'}], 'overallOfficials': [{'name': 'Christian Puelacher, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Christian Müller, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data sharing with other research groups will be the responsibility of the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, {'name': 'Kantonsspital Olten', 'class': 'OTHER'}, {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'Bürgerspital Solothurn', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}