Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-16 @ 7:48 PM
Study NCT ID:
NCT06526468
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese PE Multimodality Imaging Artificial Intelligence Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples and PEA specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-06-15', 'studyFirstSubmitQcDate': '2024-07-28', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic rate of PE', 'timeFrame': '2 years', 'description': 'Comparison before and after AI technique.'}, {'measure': 'APE risk stratification rates (low, intermediate low, intermediate high and high risk)', 'timeFrame': '2 years', 'description': 'Comparison before and after AI technique.'}, {'measure': 'Disease severity of chronic thromboembolic pulmonary disease (CTEPD)/chronic thromboembolic pulmonary hypertension (CTEPH)', 'timeFrame': '2 years', 'description': 'Comparison before and after AI technique. Assessment of disease severity is comprehensive, referring to the comprehensive risk assessment in pulmonary arterial hypertension (three-strata model) \\[DOI: 10.1183/13993003.00879-2022\\], including clinical observations and modiļ¬able variables. The higher the score, the more severe the condition.'}, {'measure': '30 day mortality', 'timeFrame': '2 years', 'description': 'Patient mortality (death) at 30-days post-PE diagnosis. Comparison before and after AI technique.'}], 'secondaryOutcomes': [{'measure': 'Rate of discordant PE cases', 'timeFrame': '2 years', 'description': 'False positive and false negative rate'}, {'measure': 'AI failure rate for PE detection', 'timeFrame': '2 years', 'description': 'Proportion of scans unable to be interpreted by AI despite suitable CTPA acquisition'}, {'measure': '12 month mortality', 'timeFrame': '2 years', 'description': 'Patient mortality (death) at 12-months post-PE diagnosis. Comparison before and after AI technique.'}, {'measure': 'Length of hospital stay for PE', 'timeFrame': '2 years', 'description': 'Comparison before and after AI technique. Measured as number of days from admission to time of discharge from hospital.'}, {'measure': 'Time from symptom onset to final diagnosis', 'timeFrame': '3 months', 'description': 'Comparison before and after AI technique.'}, {'measure': 'Hospitalization cost for PE using Markov model', 'timeFrame': '2 years', 'description': 'Comparison before and after AI technique.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['imaging', 'early diagnosis', 'differential diagnosis', 'risk stratification', 'prognosis assessment'], 'conditions': ['Pulmonary Embolism', 'Chronic Thromboembolic Pulmonary Hypertension', 'Chronic Thromboembolic Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '40825922', 'type': 'DERIVED', 'citation': 'Xi L, Wang J, Liu A, Ni Y, Du J, Huang Q, Li Y, Wen J, Wang H, Zhang S, Zhang Y, Zhang Z, Wang D, Xie W, Gao Q, Cheng Y, Zhai Z, Liu M. Development of a lung perfusion automated quantitative model based on dual-energy CT pulmonary angiography in patients with chronic pulmonary thromboembolism. Insights Imaging. 2025 Aug 18;16(1):182. doi: 10.1186/s13244-025-02067-6.'}]}, 'descriptionModule': {'briefSummary': 'The CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study (CHOICE) is a prospective observational multi-center study that will collect imaging text data and raw data of patients with pulmonary embolism (PE) in China. By combining artificial intelligence technology, it aims to identify imaging markers to assist in early diagnosis, differential diagnosis, risk stratification, and prognosis assessment of PE.', 'detailedDescription': 'Pulmonary embolism (PE) represents a significant public health issue. Timely diagnosis and treatment during the acute phase, as well as appropriate long-term follow-up strategies, are crucial for the management of PE. PE is classified into three stages based on disease course: acute pulmonary embolism (APE), chronic thromboembolic pulmonary disease (CTEPD), and chronic thromboembolic pulmonary hypertension (CTEPH). APE can cause acute right ventricular failure and death if not diagnosed and treated early. CTEPD has the potential to significantly impair patients\' quality of life. CTEPH is a rare and potentially life-threatening long-term sequelae of PE, characterized by persistent obstruction of pulmonary arteries by organized clots, leading to redistribution of blood flow and secondary remodeling of the pulmonary microvasculature. Early identification of PE and implementation of targeted treatment plans will significantly improve survival rates and prognosis.\n\nMultimodal imaging tests play a crucial role in the management of PE (including computed tomography pulmonary angiography (CTPA), magnetic resonance imaging (MRI), echocardiography, and lung ventilation/perfusion (V/Q) scan). The guidelines have identified the right ventricle to left ventricle (RV:LV) ratio \\>1.0 on CTPA or right heart dysfunction signs from echocardiography as important indicators for risk stratification of APE. Patients stratified as high risk require closer monitoring in an inpatient setting. Whereas, those stratified as low risk are suitable for early discharge.\n\nTherefore, exploring novel imaging markers and integrating these markers into radiology reports may have potential clinical significance. If no quantifiable evidence of right ventricular dysfunction is provided to clinicians to make treatment decisions, patients with high-risk APE may be considered "low-risk" and discharged home. In addition, patients with low-risk APE may require longer hospital stays and may not need to be hospitalized, which undoubtedly increases healthcare costs. For patients with CTEPD or CTEPH, treatment options are diverse, including multimodal therapies such as pulmonary endarterectomy, balloon pulmonary angioplasty and targeted medical therapy. Therefore, multimodal imaging evaluation is meaningful for clinical treatment decision-making and efficacy monitoring. Combined with artificial intelligence (AI) technology, it can provide a variety of metrics to assist in evaluating clots morphology, pulmonary ventilation-perfusion function, cardiac function, hemodynamics, and more. AI can not only assist in finding more clinically significant imaging biomarkers but also customize standardized radiology reports, which are expected to address the current challenges.\n\nThis study is a multi-center real-world study aimed at exploring novel imaging markers in combination with AI technology and integrating them into a software for clinical application to provide quantitative parameters, using imaging reports and raw data from Chinese patients with PE. It is hypothesized that AI technology can improve early diagnosis, differential diagnosis, risk stratification, and management of PE by increasing the ability to accurately evaluate PE in a real-world clinical setting. The researchers also hypothesized that the integration of AI technologies would be cost-effective and acceptable to radiologists and clinicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suspected of PE in China', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 14 Years and older\n* Patients suspected of PE\n\nExclusion Criteria:\n\n* Pregnant women\n* Refuse to follow up\n* Incomplete or discontinued imaging scans\n* Insufficient quality of image data to allow for analysis'}, 'identificationModule': {'nctId': 'NCT06526468', 'briefTitle': 'Chinese PE Multimodality Imaging Artificial Intelligence Study', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'CHinese pulmOnary Embolism Multimodality Imaging-artifiCial intelligencE Study', 'orgStudyIdInfo': {'id': 'CHOICE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute pulmonary embolism cohort', 'description': '1. Patients objectively confirmed acute symptomatic PE or PE with deep vein thrombosis (DVT)\n2. PE was confirmed by CTPA, lung V/Q scan or pulmonary angiography.', 'interventionNames': ['Device: Artificial Intelligence']}, {'label': 'Chronic thromboembolic pulmonary disease without pulmonary hypertension cohort', 'description': '1. Patients with functional impairment despite 3 months of adequate anticoagulation therapy after APE.\n2. CTPA/ pulmonary angiography or V/Q scan showed unresolved thrombi in the pulmonary vessels.\n3. Without pulmonary hypertension at rest(mean pulmonary arterial pressure (mPAP) \\<20 mmHg), as measured by right heart catheterization.', 'interventionNames': ['Device: Artificial Intelligence']}, {'label': 'Chronic thromboembolic pulmonary hypertension cohort', 'description': '1. Patients with functional impairment despite 3 months of adequate anticoagulation therapy\n2. CTPA/ pulmonary angiography or V/Q scan showed unresolved thrombi in the pulmonary vessels.\n3. With pulmonary hypertension at rest (mean pulmonary arterial pressure (mPAP) \\>20 mmHg), as measured by right heart catheterization.', 'interventionNames': ['Device: Artificial Intelligence']}, {'label': 'Other pulmonary vascular disease cohort', 'description': 'Patients diagnosed with other pulmonary vascular disease including Takayasu arteritis, pulmonary artery sarcoma, and fibrosing mediastinitis.', 'interventionNames': ['Device: Artificial Intelligence']}], 'interventions': [{'name': 'Artificial Intelligence', 'type': 'DEVICE', 'description': 'AI technology will provide novel imaging markers and generate a radiology report with relevant key slice imaging and evaluation results', 'armGroupLabels': ['Acute pulmonary embolism cohort', 'Chronic thromboembolic pulmonary disease without pulmonary hypertension cohort', 'Chronic thromboembolic pulmonary hypertension cohort', 'Other pulmonary vascular disease cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Liu, PhD', 'role': 'CONTACT', 'email': 'mikie0763@126.com', 'phone': '+86-10-84205056'}, {'name': 'Zhenguo Zhai, PhD', 'role': 'CONTACT', 'email': 'zhaizhenguo2011@126.com', 'phone': '+86-10-84206269'}, {'name': 'Min Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China-Japan Frendship hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Min Liu, PhD', 'role': 'CONTACT', 'email': 'mikie0763@126.com', 'phone': '+86-10-84205056'}], 'overallOfficials': [{'name': 'Zhenguo Zhai, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information gathered for this study will not be disclosed to any other person or entity, or for other research.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhenguo Zhai,MD,PhD', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}