Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-08 @ 1:53 AM
Study NCT ID:
NCT04118634
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study on Biomarkers of Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-13', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-10-04', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the ROC curve of biomarkers for the diagnosis of PE', 'timeFrame': '2 years', 'description': 'The ROC curve will be built, the area under the curve will be calculated with its confidence interval.'}, {'measure': 'PE related death', 'timeFrame': '7 days', 'description': 'Number of PE related death'}], 'secondaryOutcomes': [{'measure': 'Symptomatic recurrent venous thromboembolic events', 'timeFrame': '2 years', 'description': 'Number of symptomatic recurrent venous thromboembolic event'}]}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.', 'detailedDescription': 'Management of patients with acute pulmonary embolism is a serious problem. The rapid and accurate diagnosis and risk stratification of these patients is an important unmet clinical need. The aim of the study is to evaluate the value of biomarkers, alone or in combination, in the diagnosis and risk stratification of patients with suspected pulmonary embolism presenting to the emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the emergency department with suspected PE', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged ≥ 18 years that presents to an emergency department\n* With suspected PE defined as new onset of or worsening of shortness of breath or chest pain\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Life expectancy less than 3 months\n* First symptoms 15 day or more before inclusion\n* Inability to the follow-up visits\n* Therapeutic anticoagulation for any indication'}, 'identificationModule': {'nctId': 'NCT04118634', 'acronym': 'BIO-PE', 'briefTitle': 'A Registry Study on Biomarkers of Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases'}, 'officialTitle': 'Evaluation of Performances of Biomarkers in Pulmonary Embolism', 'orgStudyIdInfo': {'id': 'PE2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group with PE', 'description': 'The criteria for confirmation of PE are:\n\nPE on spiral computed tomography (CT) proximal deep vein thrombosis on ultrasound (US) thromboembolic events objectively confirmed during the follow up'}, {'label': 'Group without PE', 'description': 'The criteria for exclusion of PE are:\n\nlow or moderate clinical probability and D-dimer ELISA \\<0.50 µg/mL or \\<10xage in patients older than 50 years and negative follow up low and moderate clinical probability and negative CT and negative follow up high clinical probability and negative CT, US and follow up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yulin Li, PhD', 'role': 'CONTACT', 'email': 'lyllyl_1111@163.com'}, {'name': 'Jie Du, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yulin Li, PhD', 'role': 'CONTACT', 'email': 'lyllyl_1111@163.com', 'phone': '0086-010-64456453'}], 'overallOfficials': [{'name': 'Jie Du, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Institute of Heart, Lung and Blood Vessel Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}