Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT04609605
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-01', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improve management of acute pulmonary embolism', 'timeFrame': 'baseline', 'description': 'comparison between speckle tracking echocardiograpgy and conventional echocardiography in pulmonary embolism'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '27126645', 'type': 'BACKGROUND', 'citation': 'Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.'}, {'pmid': '8752195', 'type': 'BACKGROUND', 'citation': 'McConnell MV, Solomon SD, Rayan ME, Come PC, Goldhaber SZ, Lee RT. Regional right ventricular dysfunction detected by echocardiography in acute pulmonary embolism. Am J Cardiol. 1996 Aug 15;78(4):469-73. doi: 10.1016/s0002-9149(96)00339-6.'}, {'pmid': '28495379', 'type': 'BACKGROUND', 'citation': 'Fields JM, Davis J, Girson L, Au A, Potts J, Morgan CJ, Vetter I, Riesenberg LA. Transthoracic Echocardiography for Diagnosing Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Am Soc Echocardiogr. 2017 Jul;30(7):714-723.e4. doi: 10.1016/j.echo.2017.03.004. Epub 2017 May 9.'}, {'pmid': '31064715', 'type': 'BACKGROUND', 'citation': 'Trivedi SJ, Altman M, Stanton T, Thomas L. Echocardiographic Strain in Clinical Practice. Heart Lung Circ. 2019 Sep;28(9):1320-1330. doi: 10.1016/j.hlc.2019.03.012. Epub 2019 Apr 12.'}]}, 'descriptionModule': {'briefSummary': '1. To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography\n2. To evaluate its relationship to long term mortality.', 'detailedDescription': 'Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate \\> 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. clinical diagnosis of acute pulmonary embolism\n2. Age: 20 - 70 years.\n\nExclusion Criteria:\n\n1. coronary artery disease\n2. patient of Atrial fibrillation.\n3. Patient of impaired RV function due to chest disease (Cor-pulmonale)\n4. patient with impaired Ejection fraction (EF) \\<50%\n5. Moderate to severe valvular heart disease.\n6. Atrio-ventricular conduction disturbance.\n7. Poor echogenicity'}, 'identificationModule': {'nctId': 'NCT04609605', 'briefTitle': 'Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography', 'orgStudyIdInfo': {'id': 'speckle tracking in PE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with acute pulmonary embolism', 'description': 'speckle tracking echocardiography for patient with acute pulmonary embolism', 'interventionNames': ['Device: speckle tracking echocardiography']}], 'interventions': [{'name': 'speckle tracking echocardiography', 'type': 'DEVICE', 'description': 'speckle tracking echocardiography of right ventricle', 'armGroupLabels': ['patients with acute pulmonary embolism']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Said rashwan, master degree of cardiology', 'role': 'CONTACT', 'email': 'dr.ma7moudsaid@gmail.com', 'phone': '01007949203'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Mahmoud Said Rashwan', 'investigatorAffiliation': 'Assiut University'}}}}