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Cardiac Changes in Myeloproliferative Neoplasms

Primary Purpose

Myeloproliferative Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transthorathic echocardiogram
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myeloproliferative Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnostic criteria of myeloproliferative neoplasms.

Exclusion Criteria:

  • Extreme body weight e.g., morbid obesity.
  • Cardiac disease.
  • Cerebrovascular disorders.
  • Diabetes mellitus.
  • Dyslipidemia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    study group

    control group

    control group 2

    Arm Description

    patients with myeloproliferative neoplasms and reveal cardiac complications by using echocardiogram, intervention by using transthorathic echocardiography for all patients.

    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.

    healthy people from the same age and sex will be investigated using echocardiogram. Intervention will be in the form of using transthorathic echocardiography.

    Outcomes

    Primary Outcome Measures

    number of patients with cardiac complications in myeloproliferative diseases.
    cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2017
    Last Updated
    June 5, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03177928
    Brief Title
    Cardiac Changes in Myeloproliferative Neoplasms
    Official Title
    Functional and Morphological Cardiac Changes in Myeloproliferative Neoplasms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    August 31, 2018 (Anticipated)
    Study Completion Date
    February 28, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    According to worldwide study of prevalence of myeloproliferative neoplasms revealed: Incidence 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. Primary 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myeloproliferative Neoplasm

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    patients with myeloproliferative neoplasms and reveal cardiac complications by using echocardiogram, intervention by using transthorathic echocardiography for all patients.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    control group 2
    Arm Type
    Active Comparator
    Arm Description
    healthy people from the same age and sex will be investigated using echocardiogram. Intervention will be in the form of using transthorathic echocardiography.
    Intervention Type
    Device
    Intervention Name(s)
    Transthorathic echocardiogram
    Intervention Description
    In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.
    Primary Outcome Measure Information:
    Title
    number of patients with cardiac complications in myeloproliferative diseases.
    Description
    cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnostic criteria of myeloproliferative neoplasms. Exclusion Criteria: Extreme body weight e.g., morbid obesity. Cardiac disease. Cerebrovascular disorders. Diabetes mellitus. Dyslipidemia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Osama A Ibrahim, Proffessor.
    Phone
    00201006372498
    Email
    oibrahiem@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed B Ahmed, lecturer.
    Phone
    00201009820300
    Email
    ahmadbahei@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26299877
    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.
    Results Reference
    background
    PubMed Identifier
    27913526
    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.
    Results Reference
    background
    PubMed Identifier
    5183970
    Citation
    Campbell A. Now I know why. Front Nurs Serv Q Bull. 1968 Winter;43(3):7-9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24971434
    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. Erratum In: Am J Hematol. 2015 Sep;90(9):850.
    Results Reference
    background
    PubMed Identifier
    23768070
    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.
    Results Reference
    background
    PubMed Identifier
    27341755
    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.
    Results Reference
    background

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    Cardiac Changes in Myeloproliferative Neoplasms

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