Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT05098769
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2021-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D000075902', 'term': 'Clinical Deterioration'}], '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': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2021-10-16', 'studyFirstSubmitQcDate': '2021-10-16', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse outcomes', 'timeFrame': '30 days', 'description': 'The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission. Adverse outcomes were defined as PE-related deaths, the need for mechanical ventilation, the need for cardiopulmonary resuscitation, and the need for life-saving vasopressor and reperfusion treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Embolism and Thrombosis', 'Deterioration, Clinical'], 'conditions': ['Pulmonary Embolism and Thrombosis', 'Deterioration, Clinical']}, 'referencesModule': {'references': [{'pmid': '41174707', 'type': 'DERIVED', 'citation': 'Gao Y, Gu Z, Wei X, Wei S, Liu Y, Zhan S, Yang J, Qi C, Qi S, Wang M, Jia D. Ventricular septum curvature ratio: a novel imaging marker to predict clinical deterioration in normotensive acute pulmonary embolism. Crit Care. 2025 Oct 31;29(1):463. doi: 10.1186/s13054-025-05708-w.'}, {'pmid': '40576035', 'type': 'DERIVED', 'citation': 'Gao Y, Wei S, Liu Y, Yu Z, Zhan S, Yang B, Qi C, Qi S, Wang M, Jia D. Predicting Deterioration in Patients With Normotensive Acute Pulmonary Embolism Using Clinical-Imaging Features: A Multicenter Prospective Cohort Study. J Am Heart Assoc. 2025 Jul;14(13):e038984. doi: 10.1161/JAHA.124.038984. Epub 2025 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.', 'detailedDescription': 'This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital.\n\nEligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography\n\nExclusion Criteria:\n\n* pregnancy\n* reception of reperfusion treatment before admission\n* missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.'}, 'identificationModule': {'nctId': 'NCT05098769', 'briefTitle': 'A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using Parameters Obtained by Computed Tomographic Pulmonary Angiography.', 'orgStudyIdInfo': {'id': 'AOAPECT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute pulmonary embolism', 'description': 'an age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YIZHUO GAO', 'role': 'CONTACT', 'email': 'gaoyizhuo.sy@hotmail.com', 'phone': '+86-18940257523'}], 'facility': 'Shenjing Hospital of CHINA MEDICAL UNIVERSITY', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'YIZHUO GAO', 'role': 'CONTACT', 'email': 'gaoyizhuo.sy@hotmail.com', 'phone': '+86-18940257523'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'YIZHUO GAO', 'investigatorAffiliation': 'Shengjing Hospital'}}}}