Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 4:57 AM
Study NCT ID:
NCT05708794
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjust-Unlikely PE
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT.', 'timeFrame': '90 days following index presentation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emergency medicine', 'standardization of practice', 'diagnostics evaluation'], 'conditions': ['Pulmonary Embolism (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.\n\nThe pilot study objectives are to:\n\n1. Determine study recruitment rate, per site, per month\n2. Determine study 90-day loss to follow up rate\n3. Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule\n4. Estimate of the Adjust-Unlikely algorithm efficiency\n5. Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.\n\nThe pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to emergency departments and urgent care centres with symptoms of PE.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency physician decides to test for PE\n\nExclusion Criteria:\n\n* Tested for PE without using the Adjust-Unlikely algorithm\n* D-dimer level is known before Adjust-Unlikely assessment\n* A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant\n* Declines participation\n* Is inaccessible for follow-up\n* Has previously participated in this study'}, 'identificationModule': {'nctId': 'NCT05708794', 'briefTitle': 'Adjust-Unlikely PE', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'A Pilot Study to Assess Feasibility of Evaluating the Safety and Efficiency of a Simplified Diagnostic Approach for Pulmonary Embolism', 'orgStudyIdInfo': {'id': '4269'}}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Health Sciences Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Kerstin de Wit', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Kerstin de Wit', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Dr. Kerstin de Wit, Associate Professor, Department of Emergency Medicine, Queen's University", 'investigatorFullName': 'Dr. Kerstin de Wit', 'investigatorAffiliation': "Queen's University"}}}}