Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:04 PM
Study NCT ID:
NCT03177928
Status:
UNKNOWN
Last Update Posted:
2017-06-06
First Post:
2017-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Changes in Myeloproliferative Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with cardiac complications in myeloproliferative diseases.', 'timeFrame': '30 minutes', 'description': 'cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloproliferative Neoplasm']}, 'referencesModule': {'references': [{'pmid': '26299877', 'type': 'BACKGROUND', 'citation': 'How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2015 Sep;90(9):850. doi: 10.1002/ajh.23984. Epub 2015 Mar 30. No abstract available.'}, {'pmid': '27913526', 'type': 'BACKGROUND', 'citation': "Passamonti F, Maffioli M. Update from the latest WHO classification of MPNs: a user's manual. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):534-542. doi: 10.1182/asheducation-2016.1.534."}, {'pmid': '5183970', 'type': 'BACKGROUND', 'citation': 'Campbell A. Now I know why. Front Nurs Serv Q Bull. 1968 Winter;43(3):7-9. No abstract available.'}, {'pmid': '24971434', 'type': 'BACKGROUND', 'citation': "Titmarsh GJ, Duncombe AS, McMullin MF, O'Rorke M, Mesa R, De Vocht F, Horan S, Fritschi L, Clarke M, Anderson LA. How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2014 Jun;89(6):581-7. doi: 10.1002/ajh.23690."}, {'pmid': '23768070', 'type': 'BACKGROUND', 'citation': 'Mehta J, Wang H, Iqbal SU, Mesa R. Epidemiology of myeloproliferative neoplasms in the United States. Leuk Lymphoma. 2014 Mar;55(3):595-600. doi: 10.3109/10428194.2013.813500. Epub 2013 Jul 29.'}, {'pmid': '27341755', 'type': 'BACKGROUND', 'citation': 'Barbui T, Thiele J, Gisslinger H, Finazzi G, Vannucchi AM, Tefferi A. The 2016 revision of WHO classification of myeloproliferative neoplasms: Clinical and molecular advances. Blood Rev. 2016 Nov;30(6):453-459. doi: 10.1016/j.blre.2016.06.001. Epub 2016 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Myeloproliferative neoplasms are heterogeneous group of clonal hematopoietic stem cell neoplasms with excessive proliferation of one or more of the erythroid, megakaryocytic, or myeloid lineages and relatively normal maturation resulting in increased numbers of red cells, platelets, and/or granulocytes in the peripheral blood. Constitutive tyrosine kinase activation appears to be a common pathogenetic mechanism.', 'detailedDescription': 'According to worldwide study of prevalence of myeloproliferative neoplasms revealed:\n\nIncidence of polycythemia vera ranged 0.01 to 2.61 per 100.000 population and the prevalence ranging from 0.49 to 46.88 per 100.000 population. Incidence of essential thrombocythemia is 0.21 to 2.27 per 100.000 population, prevalence ranging between 11.00 - 42.51 per 100.000 population.\n\nPrimary myelofibrosis incidence is 1.15 -4.99 per 100.000 population and prevalence ranging between 1.76 - 4.05 per 100.000 population.In previous studies, cardiac involvement including coronary arterial thrombosis, myocardial infarction, pulmonary hypertension, asymptomatic pericardial effusion, cardiac tamponade, intractable cardiac failure due to intraventricular stenosis and valvular stenosis that occur in myeloproliferative neoplasms. There is a few number of studies in which cardiac lesions were evaluated in myeloproliferative neoplasms by using transthoracic echocardiography but still inadequate, so we need to understand more about cardiovascular complications in myeloproliferative neoplasms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic criteria of myeloproliferative neoplasms.\n\nExclusion Criteria:\n\n* Extreme body weight e.g., morbid obesity.\n* Cardiac disease.\n* Cerebrovascular disorders.\n* Diabetes mellitus.\n* Dyslipidemia.'}, 'identificationModule': {'nctId': 'NCT03177928', 'briefTitle': 'Cardiac Changes in Myeloproliferative Neoplasms', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Functional and Morphological Cardiac Changes in Myeloproliferative Neoplasms', 'orgStudyIdInfo': {'id': 'CCMPNS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group', 'description': 'patients with myeloproliferative neoplasms and reveal cardiac complications by using echocardiogram, intervention by using transthorathic echocardiography for all patients.', 'interventionNames': ['Device: Transthorathic echocardiogram']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'patients with hematological disorders including myeloproliferative neoplasms without cardiac affection by using echocardiogram. Intervention will be in the form of using transthorath echocardiography with all patients to reveal any cardiac abnormalities.', 'interventionNames': ['Device: Transthorathic echocardiogram']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group 2', 'description': 'healthy people from the same age and sex will be investigated using echocardiogram. Intervention will be in the form of using transthorathic echocardiography.', 'interventionNames': ['Device: Transthorathic echocardiogram']}], 'interventions': [{'name': 'Transthorathic echocardiogram', 'type': 'DEVICE', 'description': 'In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.', 'armGroupLabels': ['control group', 'control group 2', 'study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Osama A Ibrahim, Proffessor.', 'role': 'CONTACT', 'email': 'oibrahiem@yahoo.com', 'phone': '00201006372498'}, {'name': 'Ahmed B Ahmed, lecturer.', 'role': 'CONTACT', 'email': 'ahmadbahei@yahoo.com', 'phone': '00201009820300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'AKAli', 'investigatorAffiliation': 'Assiut University'}}}}