Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 10:45 AM
Study NCT ID:
NCT04327960
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Assessment Strategies in 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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-03-28', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary embolism-related death', 'timeFrame': 'Baseline', 'description': 'Approximately 1% of all hospitalized patients and 10% of all in-hospital mortalities are PE related. Adding to this, acute PE is linked to comparatively high (≥13%) short-term mortalities that occur either in hospital or within 30 days'}], 'secondaryOutcomes': [{'measure': 'hospital stay, need for ICU admission, need for mechanical ventilation or cardiopulmonary resuscitation or home dischage.', 'timeFrame': 'Baseline', 'description': 'patients who escape a PE-related death are still endangered by hematologic mishaps, especially recurrence of VTE and/or PE, or on the contrary, serious hemorrhage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '26738514', 'type': 'BACKGROUND', 'citation': 'Jimenez D, Lobo JL, Fernandez-Golfin C, Portillo AK, Nieto R, Lankeit M, Konstantinides S, Prandoni P, Muriel A, Yusen RD; PROTECT investigators. Effectiveness of prognosticating pulmonary embolism using the ESC algorithm and the Bova score. Thromb Haemost. 2016 Apr;115(4):827-34. doi: 10.1160/TH15-09-0761. Epub 2016 Jan 7.'}, {'pmid': '26743479', 'type': 'BACKGROUND', 'citation': 'Hobohm L, Hellenkamp K, Hasenfuss G, Munzel T, Konstantinides S, Lankeit M. Comparison of risk assessment strategies for not-high-risk pulmonary embolism. Eur Respir J. 2016 Apr;47(4):1170-8. doi: 10.1183/13993003.01605-2015. Epub 2016 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate different scores of risk assessment in patients with pulmonary embolism. This study aim to compare the accuracy of these scores in predicting mortality during hospital admission.', 'detailedDescription': 'Pulmonary embolism (PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate.Approximately 1% of all hospitalized patients and 10% of all in-hospital mortalities are PE related. Adding to this, acute PE is linked to comparatively high (≥13%) short-term mortalities that occur either in hospital or within 30 days.\n\nSome studies have demonstrated that PE may indicate increased 1-year mortality rates up to 25%,,. Therefore, PE is considered a potentially fatal disease, although patients who escape a PE-related death are still endangered by hematologic mishaps, especially recurrence of VTE and/or PE, or on the contrary, serious hemorrhage5.\n\nRisk stratification of patients with acute PE is mandatory for determining the appropriate therapeutic management approach. Risk classification of PE can discriminate low-risk patients, who can be medicated as outpatients, from others at high risk, in whom a profit from intensive care unit admission or even in-hospital thrombolytic therapy is expected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The present study is a cross-sectional study. All patients consecutively admitted to Assuit University Hospital, diagnosid with PE will be included.\n\nAt least 80 patients will be included in the present study. Sample size was calculated using Epi- Info version 7, based on a previous study conducted by Yousif and Hussein (2019), which demonstrated that the mortality rate from pulmonary embolism was 13.7%, with a confidence limit of 5% and a confidence level of 80%. To overcome the dropouts the sample may be extended to 100 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nAll patients will be subjected to the following:\n\n1. Complete history taking and clinical examination.\n2. Chest x-ray\n3. ECG and echocardiography.\n4. Arterial blood gases.\n5. Multislice CT angiography of the chest.\n6. Laboratory tests and biomarkers.\n\nExclusion Criteria:\n\n* 1- Patients with unexpected or accidental diagnosis of PE (patients undergoing diagnostic tests for another suspected disease.\n\n 2- Patients with acute left heart failure or acute respiratory failure responsible for symptoms.\n\n 3- Patient with recurrent PE (only the first event was included in the analysis).'}, 'identificationModule': {'nctId': 'NCT04327960', 'briefTitle': 'Risk Assessment Strategies in Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Risk Stratification in Pulmonary Embolism', 'orgStudyIdInfo': {'id': 'Pulmonary embolism'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac troponin (cTn)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiac troponin (cTn) will be measured with the Dimension RxL-HM analyzer .The one-step enzyme immunoassay is based on cTn specific monoclonal antibodies, performed on a separate module of the analyzer, assay-time is 17 minutes.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mariam Louiz, Master', 'role': 'CONTACT', 'email': 'mariamlouiz1990@gmail.com', 'phone': '+2012885523082'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Mariam louiz Azmy', 'investigatorAffiliation': 'Assiut University'}}}}